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

• 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

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

• 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

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

• 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:

• Lead work centers and production lines as necessary.
• Maintains assigned machinery.
• Sustains awareness of production schedule and needs.
• Independently operate several types of production machinery after the successful completion of training and certification.
• Monitors production equipment to ensure a quality product.
• Perform machine set up and changeovers on various equipment and production lines.
• Follow established quality requirements for each product.
• Complies with all procedural requirements.
• Performs troubleshooting, adjustments, and preventative maintenance of production machinery.
• Reads and interprets equipment manuals and work orders to perform required maintenance and service.
• Work with Quality Control to ensure written documentation for production runs is complete, correct, and in compliance with company Good Documentation Practices and government regulations.
• Identifies and implements necessary documentation for compliance and works with Quality Assurance to ensure compliance.
• Follows guidelines to ensure machinery, room, and materials are in compliance with QSR/ISO requirements.
• Adhere to all safety policies and procedures for operating equipment and handling raw materials and finished goods.
• Adhere to all company policies, procedures, and safety requirements.
• Maintain good housekeeping and a clean work area.
• Promote teamwork by working with others to achieve production efficiency, quality, and on-time delivery goals.
• 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:

• Associate’s degree or certificate in mechanical or industrial maintenance preferred. or equivalent.
• 2 – 4 years of manufacturing/production experience.
• Knowledge of manufacturing product flows.
• Ability to recognize and adhere to quality standards.
• Ability to read and interpret written policies and procedures.
• 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 complete paperwork fully and correctly.
• Good written and verbal communication skills.
• Ability to work with others to achieve goals.
• Ability to perform repetitive tasks.
• Proficient in Microsoft Office.
• Experience in a FDA regulated manufacturing facility preferred.
• Knowledge of GMP regulations preferred.

PHYSICAL REQUIREMENTS:

• Occasionally required to sit.
• Frequently required to talk and hear.
• 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 required.

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:

• Assists with generation and verification of bills of materials (BOMs)
• Able to review and correct drawings, grants approval to upload to document management system (ETQ)
• Competency with company drafting practices.
• Collaborate with internal functional groups and customers to develop product documentation.
• Perform or assist with troubleshooting on new and existing products.
• Design of fixtures and ancillary items as required.
• Development and implementation of experiments to assess components and finished goods.
• Drawing creation and modification using applicable software packages (CAD, Corel).
• 3D modeling and adherence to creation practices.
• Ability to utilize on-line resources to gather information and specifications.
• Develop and apply knowledge of specifications pertinent to materials, packaging components and finished goods.
• Has signature authority for Change Control approval, check and data entry check on engineering changes. Manages Design Control documentation to FDA and other regulatory requirements.
• Acts as focal for engineering documentation creation and product engineering supply to all other service groups within the company Program Management, Sales and Marketing, Purchasing, Design Engineering, Scheduling, Manufacturing Engineering, and Quality. Ensures all necessary documentation is in place prior to phase gates.
• Executes and manages design engineering projects.
• Manage schedule, and specifications on a major engineering projects.
• Support training and development of product engineering team (remote sites).
• Attend meetings as needed to support organization activity.
• Interface with customers as required.
• Travel between Unicep facilities required as an essential function of this position.
• Regular attendance.
• Other duties as assigned. 

Minimum Requirements

MINIMUM REQUIREMENTS:

• Bachelor's degree in Engineering.
• Zero to four years progressive experience in a product engineering or related engineering discipline.
• Ability to operate and have knowledge in using SolidWorks software.  Must be able to define problems, collect data, establish facts, draw valid conclusions, and demonstrate the ability to determine critical parameters
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
• Demonstrated ability with technical writing. Ability to communicate effectively, both orally and in writing to management and technical staff audiences. Ability to stand in front of small to large technical audiences and provide training.
• Demonstrated organizational skills, with the ability to handle and prioritize multiple projects simultaneously in a timely manner in a fast-paced environment.
• Must have knowledge of use and operation of MS Office, email, and Internet.
• Must have a high level of interpersonal skills to handle sensitive and confidential situations and materials. Position continually requires demonstrated poise, tact, and diplomacy.
• Ability to work both independently with little direction and as part of a team.
• Experience in a FDA-regulated facility preferred.
• Knowledge of GMP regulations preferred.
• Ability to identify and define problems, gather data, generate valid conclusions and convey results appropriately.
• Applies theory backed by knowledge gained thru experience to provide direction and base decisions.

PHYSICAL REQUIREMENTS:

• Frequently required to sit and walk.
• Frequently required to walk up and down stairs.
• Frequently required to talk and hear.
• Fine motor control to grasp and manipulate objects.
• Occasionally required to bend at the waist and knees.
• 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.