Essential Responsibilities

• Establish and maintain an understanding of Unicep’s products and services and how they are applied in each market segment we serve.
• Serve as point of contact for assigned customers/programs.
• Provide project updates to supported APMs, PMs, and Management as necessary.
• Assist with the administration of the Quote process with a basic understanding of cost drivers, customer business needs and Unicep’s sales processes. Quote process entails interaction with quote team, suppliers, customers and sales executives.
• Input quote data into spreadsheet form for analysis and reporting.
• Process and enter Sales Orders.
• Assist APMs, PMs, and Management to administer customer contracts.
• Assist with New Product Introduction (NPI), product transfers, and end-of-life activities.  Generate and tracks cross-functional action item lists and ensure alignment with customer expectations.
• Assist with ongoing production for established programs by leading cross-functional teams, as required, to ensure that programs are conducted in accordance with the requirements of sales orders and program objectives, elevating unresolved issues to management. 
• Assist APMs and PMs with managing cash flow, budgets, forecasts, profit & loss, program timelines, resources, and key milestones.
• Write Work Orders and obtain required signatures.
• Identify and support development of organic growth opportunities with existing customer base.
• Generate, maintain and publish reports on cost, margins, and inventory levels.
• Ensure compliance with GMP, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.
• Maintain regular attendance.
• Adhere to company safety requirements.
• Perform other duties as assigned.

Minimum Requirements

• Bachelor's degree in engineering or business preferred.
• Experience in an FDA regulated manufacturing facility preferred.
• Knowledge of GMP regulations preferred.
• Basic knowledge of cost accounting and materials procurement preferred.
• Proven proficiency in managing timelines.
• Ability to read, analyze, and interpret common scientific and technical publications and reports.
• Ability to clearly and effectively communicate in both oral and written formats.
• Ability to effectively present information and respond to questions.
• Proficient with applied business and economic mathematics and analysis.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and to deal with several abstract and concrete variables.
• Proficient in Microsoft Office products including Word, Excel & Project.
• Experience working in CRM databases with proficiency in Salesforce preferred.

PHYSICAL REQUIREMENTS:

• Regularly required to talk and hear.
• Frequently required to walk.
• Frequently required to sit.
• Occasionally required to stand.
• Occasionally lift and/or move up to 25 pounds.
• Vision includes close vision, color vision and distance vision.
• Ability to travel by air or car to meet with customers.

Reasonable accommodation may be made to enable those individuals who are disabled as defined by the Americans with Disabilities Act to perform the essential functions of this job.

Essential Responsibilities

• Establish and maintain understanding of Unicep’s products and services and how they are applied in each market segment we serve.
• Serve as primary or secondary point of contact for assigned customers/programs.
• Develop a keen understanding of customer requirements by market segment
• Administer the Quote process with a fundamental understanding of cost drivers, customer business needs and Unicep sales processes. Quote process entails interaction with quote team, suppliers, customers and sales executives.
• Successfully acquire customers through conversion of qualified leads.
• Work with Management to negotiate and administer customer contracts.
• Manage New Product Introduction (NPI), product transfers, and end-of-life activities.  Generate and track cross-functional action item list and ensure alignment with customer expectations.
• Sustain ongoing production for established programs by leading cross-functional teams, as required, to ensure that programs are conducted in accordance with the requirements of sales orders and program objectives, elevating unresolved issues to management. 
• Manage cash flow, budgets, forecasting, profit & loss, program timelines, resources, and key milestones.
• Identify and develop organic growth opportunities with existing customer base.
• Generate, maintain and publish reports on cost, margins, manufacturing variances, and inventory levels.
• Advise management of program status on a regular basis.
• Ensure compliance with GMP, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.
• Travel to Unicep Sandpoint manufacturing facility and to customer sites as necessary to support projects.
• Maintain regular attendance.
• Adhere to company safety requirements.
• Perform other duties as assigned.

Minimum Requirements

• Bachelor’s degree in engineering or business, or an equivalent combination of education and experience.
• 2-4 years’ experience in engineering, high volume assembly management, procurement, or finance; or an equivalent combination of education and experience.
• Experience in an FDA regulated manufacturing facility preferred.
• Knowledge of GMP regulations.
• Knowledge of cost accounting, profit & loss statements and materials procurement.
• Proven proficiency in managing timelines.
• Ability to read, analyze, and interpret common scientific and technical publications and reports.
• Ability to clearly and effectively communicate in both oral and written formats.
• Ability to effectively present information and respond to questions.
• Proficient with applied business and economic mathematics and analysis.
• Ability to define problems, collect data, establish facts and draw valid conclusions.
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
• Proficient in Microsoft Office products including Word, Excel, and Project.
• Experience working in CRM databases with proficiency in Salesforce preferred.
• Fundamental understanding of quote process.
• Fundamental understanding of cost drivers in business.
• Excellent interpersonal skills.

PHYSICAL REQUIREMENTS:

• Regularly required to talk and hear.
• Frequently required to walk.
• Frequently required to sit.
• Occasionally required to stand.
• Occasionally lift and/or move up to 25 pounds.
• Vision includes close vision, color vision and distance vision.
• Ability to travel by air or car to meet with customers.

Essential Responsibilities

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Works on a production line packaging products, following written guidelines and specifications for each product.
• Independently operates production machinery after the successful completion of training and certification.
• Follows established quality requirements for each product.
• Adheres to all safety policies and procedures for operating equipment and handling raw materials and finished goods.
• Cross train to other work stations to enable rotation of work.
• Adheres to all company policies and procedures.
• Maintains good housekeeping and a clean work area.
• Promotes teamwork by working with others to achieve production efficiency, quality, and on-time delivery goals.
• Regular attendance is an essential function of this position
• Ensure compliance with GMP, QSR/ISO, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.
• Adheres to company safety requirements.
• Other duties as assigned.

Minimum Requirements

MINIMUM REQUIREMENTS:

• High school diploma or equivalent.
• Prior experience in a FDA regulated manufacturing facility preferred.
• Knowledge of GMP regulations preferred.
• Prior experience working on a production line preferred.
• Ability to read and interpret written policies and procedures.
• Ability to complete paperwork correctly.
• Ability to add, subtract, multiply and count.
• Good written and verbal communication skills.
• Ability to work with others to achieve goals.
• Ability to perform repetitive tasks.
• Ability to recognize good quality and perform to quality standards.

PHYSICAL REQUIREMENTS:

• Varied position throughout shift, including standing and/or sitting for up to 2 hours at a time.
• Frequently required to talk and hear.
• Frequently required to stand and walk.
• Frequently required to lift and/or move up to 25 pounds.
• Occasionally required to lift and/or move up to 50 pounds.
• Good manual dexterity.
• Ability to grasp small objects.
• Vision ability including close vision, distance vision, color vision, and the ability to adjust focus.

Reasonable accommodation may be made to enable those individuals who are disabled as defined by the Americans with Disabilities Act to perform the essential functions of this job.

Essential Responsibilities

• Schedule and manage third-party contractors, ensuring compliance with all company policies and procedures, and regulatory requirements.
• Analyze, implement and train layout of equipment, workflow, production methods and workforce utilization and implement processes and procedures to maximize efficiency.
• Work autonomously to re-design, repair or replace in-process production program equipment, production control hardware, and tooling.
• Develop and document Standard Operating Procedures (SOPs), Work Instructions, and troubleshooting processes, methods, tooling and production controls for new programs. Train Manufacturing Engineers and Machine Technicians in these areas.
• Follow guidelines to assure machinery, room, and materials are in compliance with QSR/ISO requirements.
• Identify and implement necessary documentation for compliance and interact with QA to ensure compliance.
• Write procedures and train others on the operation of new or existing equipment.
• Stay informed concerning new manufacturing technology and equipment, and investigate their potential application. Recommend incorporation of new technology for company applications where feasible and practical.
• As part of the New Product Introduction process, review material Safety Data Sheets for safety compliance.
• Participate in the process to quote new products.
• Prepare specifications and source new equipment.
• Prepare User Requirement Specifications/FS for new equipment.
• Perform validation document review for new equipment.
• Plan and execute the preventive maintenance program.
• Lead continuous improvement efforts using lean manufacturing principles.
• Prepare and manage capital projects including identifying scope, cost, milestones, etc.
• Serve as a key resource for safety related issues with the goal of meeting/exceeding OSHA requirements for a safe workplace.

Minimum Requirements

• Bachelors degree in Mechanical Engineering, or a related field, or an equivalent combination of education and experience
• 3-5 years manufacturing experience
• Demonstrated ability to lead people and get results through others
• Knowledge of building codes
• Preventive maintenance experience
• Ability to work independently with minimal supervision
• Strong mechanical aptitude and working knowledge of electrical and mechanical systems
• Good troubleshooting and diagnostic skills
• Ability to prioritize workload to meet established timelines
• Prior experience in FDA manufacturing facility and GMP regulations preferred

Essential Responsibilities

Minimum Requirements

• 2-4 years of maintenance technician experience.
• Associate’s degree or certificate in mechanical or industrial maintenance preferred.
• Knowledgeable in pneumatics, electrical, and mechanical systems diagnosis.
• Ability to use a variety of hand, and diagnostic tools.
• Frequency Drive, and PLC experience is a plus.
• Knowledge of manufacturing product flows.
• Ability to recognize and adhere to quality standards.
• Ability to follow written and verbal instruction.
• Ability to work independently with little direction.
• Ability to work as part of a team to complete projects.
• Ability to travel by car to support multiple-site facility.
• Proficient in Microsoft Office.
• Experience in a FDA regulated manufacturing facility preferred.
• Knowledge of GMP regulations preferred.

Essential Responsibilities

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Oversees the daily performance of the IT systems.
• Ensures the reliability, efficiency, and confidentiality of the IT system.
• Manages the network infrastructure and connectivity, including wide area, local area, and remote access capabilities.
• Responsible for hardware maintenance, software support, network and remote backups, system upgrades and Internet support for the company.
• Utilizes enterprise resource planning (ERP) techniques for the coordination of multisite IT systems.
• Orders and sets up equipment for employee use, performing and ensuring proper installation of cables, operating systems, and appropriate software.
• Creates and maintains computer validation program, ensuring key deadlines are met.
• Develops training materials/procedures and trains users in the proper utilization of hardware and software applications.
• Troubleshoots systems problems with users to determine the root cause(s), and takes the necessary steps to resolve.  Maintains records of daily communications, problems, and actions taken.
• Develops and maintains systems with provision for continuity of operations during any disaster recovery or other emergency situations.
• Works with all departments and outside computer support vendors to provide support to all users.
• Creates and manages IT budget, adhering to company fiscal plan.
• Identifies future requirements and evaluates and recommends software and hardware to maximize productivity.  Works with management to establish requirements for new systems or modifications to current systems.  Coordinates the installation of new systems and updates to current systems.  Perform testing for all new or modified systems.
• Ensures compliance with GMP, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.
• Provides high level of customer service with a sense of urgency.
• Regular attendance is an essential function of this position.
• Adheres to company safety requirements.
• Other duties as assigned.

Minimum Requirements

MINIMUM REQUIREMENTS:

• Bachelor’s degree in Computer Science or a related technical field or an equivalent combination of education and experience.
• Minimum three (3) years of IT experience.
• Working knowledge of networking systems including WAN and LAN.
• Working knowledge of Windows Operating Systems and personal computers.
• Knowledge of relational databases.
• Good analytical skills, coupled with excellent written and oral communication skills to explain technical information to system users.
• Ability to work independently with little direction.
• Ability to make sound decisions based on the needs of the business.
• Excellent project and program management skills.
•  

PREFERRED DUTIES, RESPONSIBILITIES AND SKILLS

• Experience with MAS 90 preferred.
• Experience writing reports from a database.
• Create and run routine reporting from the database.
• Design, write and implement special reports from the database.
• Experience in a FDA regulated facility preferred.
• Knowledge of GMP regulations preferred
• Ability to travel for support of both Unicep facilities..

PHYSICAL REQUIREMENTS:

• Frequently required to sit and walk.
• Frequently required to walk up and down stairs.
• Frequently required to talk and hear.
• Occasionally required to stand.
• Occasionally lift and/or move up to 20 pounds.
• Vision ability including close vision, distance vision, color vision and the ability to adjust focus.

Essential Responsibilities

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Measure, weigh, mix, and dispense chemicals while mixing product.
• Clean and sanitize mixing room equipment.
• Operate mixing room equipment.
• Review and record data.
• Maintain accurate production records, including (but not limited to) totals, number of rejects, and accounting for bulk product.
• Regular attendance is an essential function of this position
• Ensure compliance with GMP, QSR/ISO, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.
• Adhere to company safety requirements.
• Other duties as assigned.

Minimum Requirements

MINIMUM REQUIREMENTS:

• High school diploma or equivalent.
• Experience in a manufacturing setting preferred.
• Understanding of chemicals and their handling preferred.
• Ability to multitask.
• Good attention to detail.
• Ability to add, subtract, multiply, divide, and count.
• Good communication skills.
• Ability to understand and follow written and verbal procedures and instructions.
• Ability to work independently with little direction in a fast paced environment.
• Ability to work as a member of a team.
• Experience in a FDA regulated manufacturing facility preferred.
• Experience with ISO, GMP and/or GLP standards preferred.

Essential Responsibilities

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Develops, implements and manages quality control systems designed to ensure continuous production of all customer products and projects.  Works closely with the labs supervisor to plan, direct and coordinate the day-to-day operational activities of the microbiology and analytical labs.
• Oversees the coordination of testing with outside laboratories and internal demands, departments and customer requirements
• Works with Director of Quality and Regulatory Affairs on the quoting process for laboratory work.
• Responsible for the oversight and management of the Quality Control budget and meeting corporate goals.
• Manage the procurement, analysis and coordination of the data needed for Annual Product Reviews.
• Ensure compliance with applicable quality and regulatory requirements (qualified/trained staff, validated equipment, proper documentation practices, method qualifications, etc.).
• Ensure test methods and production processes meet specified protocol or SOP requirements, are scientifically sound and are performed error-free.
• Oversee testing of water (USP), Work in progress, raw materials, environmental monitoring, and finished goods.
• Participate in audits by customers or regulatory agencies.
• Address observations or recommendations as well as implement corrective/preventive actions as needed for both internal and external audits.
• Notify the organization of Out of Specification test results and coordinates the interpretation of what the results mean and how to proceed.
• Perform a failure investigation identifying root cause and take corrective/preventive action in the event of a testing and/or product failures.
• Meet customer expectations for timeliness of lab studies and product shipments.
• Directs the analysis and resolution of internal and/or external delays as well as identify trends, recommend improvements and implement improvement activities to achieve annual on-time objectives.
• Insure exceptional customer service to internal and external customers is provided by the laboratories.
• Regular attendance.
• Adhere to company safety requirements.
• Other duties as assigned.

Minimum Requirements

MINIMUM REQUIREMENTS:

• Bachelor’s degree in Chemistry, Microbiology, or a related field.
• 5-10 years lab experience.
• Detailed knowledge of biohazard and USP requirements.

• Minimum 5 years’ experience supervising employees in an FDA regulated environment preferred.
• Must be able to pass Better Process Control School course pertaining to FDA regulations applying to low acid and acidified foods within 30 days of hire.

• Experience with ISO, GMP and/or GLP standards required.
• Experience with laboratory practices including analytical methods and microbiology methods.
• Knowledge of the scientific method, chemical products, test procedures, and composition of raw materials.
• Knowledge of chemical terminology and units of measure.
• Ability to initiate, perform, and complete reports in a timely manner.
• Ability to work independently with little direction in a fast-paced environment.
• Ability to travel via car to support multiple facility locations.
• Good interpersonal skills.
• Ability to schedule projects and meet tight deadlines.
• Proficient in Microsoft Office Suite.

PHYSICAL REQUIREMENTS:

• Frequently required to sit, talk and/or hear.
• Frequently required to stand and walk.
• Occasionally required to stoop or bend.
• Regularly lift and/or move up to 25 pounds.
• Occasionally lift and/or move up to 50 pounds.
• Vision ability including close vision, distance vision, color vision and the ability to adjust focus.
• Frequently required to work with chemicals. MSDS sheets are provided.

Essential Responsibilities

• Supervise and offer leadership to employees in accordance with policies and guidelines.
• Interview, hire, and train employees, plan, assign, and direct work; appraise performance; reward and discipline employees; address complaints, and resolve problems as needed.
• Identify quality-related training needs and deliver training throughout the company.
• Assist with the quality management strategy and assist in setting policy, quality goals, and milestones.
• Participate in change and problem-solving teams; be an agent for compliant change.
• Administer the Corrective and Preventive Action (CAPA) program and Deviation and Nonconforming (NCR) programs against defined parameters. Ensure that CAPAs, Deviations and NCR's are documented; work with other departments to coordinate investigations, including the development of a plan, implementation, risk mitigation, and verification of effectiveness of the plan. Log, track, and ensure that the CAPA, Deviation and NCR procedures are maintained in a compliant state.
• Administer Nonconformance system. Ensure that nonconformances are documented; work with other departments to coordinate investigations, including the development of a plan, implementation, and verification of effectiveness of the plan. Log, track, and ensure that the Nonconformance procedure is maintained in a compliant state.
• Administer the Deviation system. Ensure that deviations are documented; work with other departments to coordinate investigations, including the development of a plan, implementation, and verification of effectiveness of the plan. Log, track, and ensure that the Deviation procedure is maintained in a compliant state.
• Administer the Internal Audit Program. Ensure procedures are maintained, training is provided for internal auditors, annual audits scheduled, and responsibilities assigned to audit team. Coordinate the generation of corrective actions for audit findings and ensure follow up from responsible parties.
• Analyze audit data and prepare reports for management review and continuous improvement initiatives.
• Handle Customer Complaints, including: logging, tracking, investigating, and responding back to the customer.  
• Participate in regulatory and customer audits.
• Ensure compliance GMP, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.
• Adhere to company safety requirements.
• Regular attendance.

Minimum Requirements

MINIMUM REQUIREMENTS:

• Bachelor’s degree in Chemistry, Engineering, or a related field, or a combination of equivalent education and experience.
• Minimum 5 years’ experience providing GMP regulatory compliance in Manufacturing or Quality Assurance.
• Minimum 3 years’ experience in an FDA facility.
• Prior experience in a pharmaceutical manufacturing facility.
• Knowledge of GMP, ISO 9000, and FDA requirements.
• Proven experience implementing and managing quality systems in a GMP environment.
• Auditing certification preferred.
• ASQ certification preferred.
• Prior supervisory experience.
• Excellent communication skills, both verbal and written.
• Excellent analytical and problem solving skills.
• Strong leadership skills.
• Proficient with Microsoft Office products, including Word and Excel.
• Ability to work both independently and as a member of a team.
• Ability to prioritize tasks to meet established timelines.
• Excellent attention to detail and good organizational skills.

PHYSICAL REQUIREMENTS:

• Frequently required to sit, talk, and hear.
• Frequently required to stand and walk.
• Occasionally required to stoop or bend.
• Regularly lift and/or move up to 20 pounds.
• Vision ability including close vision, distance vision, color vision, and the ability to adjust focus.

Reasonable accommodation may be made to enable those individuals who are disabled as defined by the Americans with Disabilities Act to perform the essential functions of this job.

Essential Responsibilities

• Works closely with Manufacturing and Automation Engineering to create, update, and maintain equipment User Requirements Specifications.
• Support design, fabrication, and upgrades for manufacturing equipment as directed by Automation Engineering Manager.
• Troubleshooting and corrective actions to support equipment issues. Provide guidance and training for maintenance technicians and operations on related activities.
• Works closely with Automation Engineering Manager and PLC Engineer to facilitate machine upgrades and modifications.
• Works with Manufacturing and Maintenance to maintain accuracy, location, and completion of equipment manual, work instructions, and log books.
• Provide guidance on machine maintenance requirements.
• Ability to collect data from multiple sources and propose prioritization to fix, standardize, and incorporate new capabilities for manufacturing equipment.
• Project technical lead, with responsibility for project management activities.
• Work with outside vendors and consultants.
• Draft specifications for mechanical, electrical, and control components.
• Support new company initiatives in the areas of Manufacturing and Operations.
• Support compliance with FDA, ISO, OSHA, and all other regulatory requirements in compliance with company policy.
• Adhere to company safety requirements.
• Regular attendance.
• Other duties as assigned.

Minimum Requirements

MINIMUM REQUIREMENTS:

• Bachelor’s degree in Electrical, Automation, Robotics, Mechanical, or Computer engineering, or equivalent education and experience.
• Five or more years’ experience in Engineering with strong automation design and troubleshooting responsibilities.
• Experience with eMaint CMMS is preferred.
• Experience with SolidWorks is preferred.
• Experience with electrical wiring.
• Experience with technical writing.
• Experience in PLC logic and programming is desirable.
• Experience in a FDA regulated manufacturing facility preferred.
• Good communication and interpersonal skills.
• Good analytical skills.
• Ability to work both independently with little direction, and as a member of a team.
• Ability to manage several projects at once to meet established timelines is essential.
• Proficient in Microsoft Office products.
• Proven ability to develop and implement standard engineering practices, as well as provide detailed documentation upon completion.

PHYSICAL REQUIREMENTS:

• Frequently required to talk and hear.
• Frequently required to stand and walk.
• Frequently required to stoop or bend.
• Regularly required to lift and/or move up to 20 pounds.
• Occasionally required to lift and/or move up to 50 pounds.
• Fine motor control to grasp and manipulate objects.
• Vision ability including close vision, distance vision, color vision and the ability to adjust focus.
•  

Essential Responsibilities

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Establish and maintain understanding of Unicep’s products and services and their applications in each market segment we serve.
• Schedule and execute marketing campaigns, including coordination of ad placements and creation and distribution of electronic materials.
• Maintain Unicep website to ensure it reflects current marketing and sales objectives.  
• Perform website analysis and keyword research to inform SEO strategies.
• Maintain marketing materials for Unicep including (but not limited to) display ads, brochures, product samples, and promotional items.
• Engage with contract service providers to support the design and creation of Unicep marketing materials.
• Collaborate with Business Development to develop and implement sales/marketing programs to support sales and expand Unicep’s customer base.
• Assist in the development of the annual marketing budget.
• Ensure compliance with GMP, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.
• Adhere to company safety requirements.
• Perform other duties as assigned.
• Regular attendance is an essential function of this position.

Minimum Requirements

MINIMUM REQUIREMENTS:

• Bachelor’s degree in Marketing, Business, or related field or a combination of equivalent education and experience required.
• Minimum 2 years’ experience in Marketing or Business Development
• Strong organization skills with an ability to work independently with little direction.
• CRM experience desired with Salesforce experience preferred.
• Proficiency with Microsoft Office products required.
• Experience in an FDA regulated manufacturing facility preferred.
• Knowledge of GMP regulations preferred.

PHYSICAL REQUIREMENTS:

• Frequently required to sit, talk, and hear.
• Frequently required to stand and walk.
• Regularly required to lift and/or move up to 20 pounds.
• Vision ability including close vision, distance vision, color vision and the ability to adjust focus.

Essential Responsibilities

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Supports Machine Technicians in the troubleshooting, repairs, and maintenance of production equipment.
• Assesses variance reports and outlines appropriate action items to ensure quality of product, reduce machine downtime, and improve machine efficiency.
• Provides support for engineering on process development, execution of engineering studies, and continuous improvement activities.
• Trains new or cross-train employees in packaging equipment operations.
• Manages spares, wears, consumables, and changeover parts to support production needs and equipment maintenance activities.
• Develops and documents equipment settings.
• Writes and updates equipment work instructions including setup, operating, cleanup, troubleshooting, and maintenance activities.
• Monitors production equipment to ensure processes stay in control and quality standards are met.
• Implements lean tools on the production floor.
• Maintains machinery for all production operations.
• Sustains awareness of production schedule and needs.
• Complies with all procedural requirements.
• Performs troubleshooting, adjustments, and preventive maintenance of production machinery.
• Reads and interprets equipment manuals and work orders to perform required maintenance and service.
• Follows guidelines to ensure machinery, room, and materials are in compliance with QSR/ISO requirements.
• Identifies and implements necessary documentation for compliance and works with Quality Assurance to ensure compliance.
• Ensures compliance with GMP, FDA, OSHA, and other regulatory requirements, in accordance with company policy.
• Adhere to company safety requirements.
• Regular attendance.
• Other duties as assigned.

Minimum Requirements

MINIMUM REQUIREMENTS:

• 5 years’ experience in manufacturing production experience. Associate’s degree or certificate in mechanical or industrial maintenance preferred.
• Knowledge of manufacturing product flows.
• Ability to recognize and adhere to quality standards.
• Ability to follow written and verbal instruction.
• Ability to work independently with little direction.
• Ability to work as part of a team to complete projects.
• Proficient in Microsoft Office.
• 2 years’ experience in a FDA regulated manufacturing facility preferred.
• Knowledge of GMP regulations preferred.
• Ability to multitask.
• Good math skills.
• Prior experience directing the work of others.
• Travel between facilities to support operations is an essential function of this position.

PHYSICAL REQUIREMENTS:

• Frequently required to talk and hear.
• Occasionally required to sit.
• Frequently required to walk.
• Required to stand for 3-4 hours at a time.
• Regularly lift and/or move up to 25 pounds.
• Occasionally lift and/or move up to 50 pounds.
• Fine motor control to grasp and manipulate objects.
• Frequently required to bend at waist and knees.
• Frequently required to reach.
• Vision ability including close vision, distance vision, color vision and the ability to adjust focus.
• Frequently required to work with products that contain chemicals or may contain hazardous materials. MSDS sheets are provided.

Essential Responsibilities

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Support the day-to-day Production activities under the direction of the Production Supervisor, ensuring compliance with established and approved policies and procedures.
• Lead Production employees in the manufacture and packaging of products.
• Provide leadership for employees through effective communications, coaching, and training and development.
• Ensure appropriate staffing levels based on production needs. Assist with the creation and maintenance of the weekly production schedule.
• Effectively use labor, materials, and support services to meet quality standards, production schedules and profit plans.
• Provide technical guidance for Production Operators, including troubleshooting.
• Provide Production metrics as requested.
• Promote and participate on Continuous Improvement Teams (CIT).
• Lead by example by promoting good manufacturing principles.
• Ensure compliance with company standards for cost control, waste reduction, quality, OSHA, safety, and complete and on-time delivery at the lowest possible cost.
• Ensure compliance with GMP, QSR/ISO, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.
• Regular attendance.
• Other duties as assigned.

Minimum Requirements

MINIMUM REQUIREMENTS:

• High school diploma or equivalent.
• Experience in a FDA manufacturing facility preferred.
• Must be able to pass Better Process Control School course pertaining to FDA regulations applying to low acid and acidified foods within 30 days of hire.
• Supervisory experience in a manufacturing environment preferred.
• Good knowledge of GMP regulations.
• Experience with materials and inventory management, production scheduling, and preventive maintenance preferred.
• A demonstrated ability to lead people and get results through others.
• Process manufacturing experience preferred.
• Knowledge of lean manufacturing techniques preferred.
• Excellent interpersonal and communication skills.
• Excellent project management skills.
• Proficient with computer systems and the ability to use programs including word processing, spreadsheets, databases, modeling, graphics, and presentation software.

PHYSICAL REQUIREMENTS:

• Frequently required to stand and walk.
• Frequently required to sit, talk, and hear.
• Frequently required to lift and/or move up to 20 pounds.
• Occasionally required to lift and/or move up to 50 pounds.
• Vision ability including close vision, distance vision, color vision and the ability to adjust focus.

Reasonable accommodation may be made to enable those individuals who are disabled as defined by the Americans with Disabilities Act to perform the essential functions of this job.

Essential Responsibilities

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Comprehension and the ability to produce at a minimum the following:
  • User Requirement Specifications (URS)
  • Engineering Studies (ES)
  • Master Batch Records (MBR)
  • Artwork Masters (AW)
  • Work Instructions (WI)
  • Standard Operating Procedures (SOP)
  • Change Requests (CR)
  • Document Control Module Requests (DCM)
• Ensures standardization of documents.
• Interacts and collaborates with technical personnel documenting content in a concise and coherent manner for both technical and non-technical personnel.
• Utilizes controlled document archive (EtQ).
• Utilizes, manipulates, and incorporates image files as appropriate.
• Attends meetings pertinent to written documents and redlines, updates and incorporates as required.
• Makes recommendations for content and format of written documents.
• Ensures alignment or written production documents with applicable requirements (customer & internal).
• Participates in document reviews.
• Writes CRs and DCMs as necessary for document changes.
• Works independently and in team environment.
• Can gather missing information from various sources (electronic and employee).
• Works to deadlines and project time-lines.
• Can convey all steps and sequence thereof to help establish time lines.
• Manages multiple projects in parallel and communicates constraints appropriately.
• Adheres to group operating procedures.
• Ability to lead review of documents.
• Mentors in areas of expertise as necessary.

• Adhere to company safety requirements.
• Regular attendance.
• Other duties as assigned.

Minimum Requirements

MINIMUM REQUIREMENTS:

• Knowledge of company practices to develop technical documentation.
• Prior experience writing technical documents.
• Four-year college degree or five years or more of experience in a comparable position.
• Prior experience in a FDA-regulated manufacturing facility preferred.
• Knowledge of GMP requirements preferred.
• Experience formatting documents to comply with established guidelines.
• Ability to follow written and oral instruction.
• Strong organizational skills.
• Strong interpersonal skills to communicate effectively at all levels within the organization.
• Proven ability to meet established timelines.
• Ability to work both independently and as a member of a team.
• Good attention to detail.
• Proficient with Microsoft Office products, including Word and Excel.

PHYSICAL REQUIREMENTS

• Frequently required to sit, talk, and hear.
• Frequently required to stand and walk.
• Regularly required to lift and/or move up to 25 pounds.
• Vision ability including close vision, distance vision, color vision and the ability to adjust focus.

Reasonable accommodation may be made to enable those individuals who are disabled as defined by the Americans with Disabilities Act to perform the essential functions of this job.

Essential Responsibilities

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Responsible for setting department objectives and securing resources to meet company strategic goals.
• Supervise Manufacturing Engineers, and facilities and maintenance empolyees.

• Provides leadership for employees through effective communication, coaching, training, and development.
• Provides leadership for problem resolution to facilitate fast improvements and improved working relationships.
• Develops and implements a culture of continuous improvement through the utilization of self-directed work teams.

• Leads design engineering related to new product development and product & systems enhancements.
• Develops and oversees the facility maintenance and preventive maintenance program, ensuring timelines are met.
• Develops and oversees machine and process validation programs, ensuring validation timelines are met.
• Work with production to be aware of production schedule and needs, ensuring manufacturing engineering is working as a team with production to achieve goals.
• Prepare and manage capital projects including identifying scope, cost, milestones, etc.
• Establishes, prepares, implements, revises, and maintains policies and procedures related to engineering and facilities.
• Regular attendance is an essential function of this position.
• Ability to travel by car or air to various facilities or customer sites.
• Other duties as assigned.

Minimum Requirements

MINIMUM REQUIREMENTS:

• Bachelor’s degree in engineering.
• PE designation preferred.
• 8-10 years progressive engineering experience.
• Prior supervisory experience.
• Demonstrated ability to lead people and get results through others.
• Knowledge of cGMP requirements for the pharmaceutical industry preferred.
• Good communication and interpersonal skills.
• Demonstrated project management experience.
• Proficient with Microsoft Office (Word, Excel, Project).
• Ability to manage multiple projects and prioritize to meet established timelines.

PHYSICAL REQUIREMENTS:

• Frequently required to talk or hear.
• Frequently required to sit, stand, and walk.
• Occasionally required to stoop or bend.
• Regularly lift and/or move up to 20 pounds.
• Occasionally lift and/or move up to 50 pounds.
• Vision ability including close vision, distance vision, color vision and the ability to adjust focus.

Reasonable accommodation may be made to enable those individuals who are disabled as defined by the Americans with Disabilities Act to perform the essential functions of this job.

Essential Responsibilities

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Write technical documents for business processes, procedures, and training.
• Consult with subject matter experts to ensure a clear understanding of documentation to be produced
• Compile and analyze source material to be used to create technical documents.
• Coordinate editing, composition, production, and delivery in accordance with specifications, standards, and other requirements.
• Recommend use of layouts, graphics, drawings, tables, exhibits, illustrations, and charts to clarify objectives.
• Coordinate Quality Control activities to ensure technical documents are accurate and adequate, including in-process and final reviews.
• Review existing documents and make recommendations and revisions to scope, format, testing, methods of production, and dissemination. 
• Maintain corporate standards for all technical documents.
• Perform periodic audits and reviews of technical documents to determine if updates and/or changes are required.
• Maintain change control procedure in compliance with regulatory guidelines and company policy.

• Coordinate the routing of change controls for pre- and post-approval. 
• Coordinate with responsible parties to ensure that activities are completed as needed, or coordinate with Program Manager on New Product Introductions to ensure that all activities are completed in the order required and in a timely manner.
• Create and release production documentation packages.
• Route and track proposed documents for final release.
• Ensure compliance with GMP, FDA, OSHA, QSR and all other regulatory requirements, in accordance with company policy.
• Adhere to company safety requirements.
• Regular attendance.
• Other duties as assigned.

Minimum Requirements

MINIMUM REQUIREMENTS:

• Knowledge of engineering practices to develop technical documentation.
• Prior experience writing technical documents.
• High school diploma or equivalent.
• Prior experience in a FDA-regulated manufacturing facility preferred.
• Knowledge of GMP requirements preferred.
• Experience formatting documents to comply with established guidelines.
• Ability to follow written and oral instruction.
• Strong organizational skills.
• Strong interpersonal skills to communicate effectively at all levels within the organization.
• Proven ability to meet established timelines.
• Ability to work both independently and as a member of a team.
• Good attention to detail.
• Proficient with Microsoft Office products, including Word and Excel.

PHYSICAL REQUIREMENTS

• Frequently required to sit, talk, and hear.
• Frequently required to stand and walk.
• Regularly required to lift and/or move up to 20 pounds.
• Vision ability including close vision, distance vision, color vision and the ability to adjust focus.

Reasonable accommodation may be made to enable those individuals who are disabled as defined by the Americans with Disabilities Act to perform the essential functions of this job.