Essential 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

• 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

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

• 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:

• Design new machinery and ancillary equipment to support company goals.
• Design components, assemblies and create functional drawings using SolidWorks.
• Work with outside vendors and consultants.
• Draft specifications for mechanical, electrical and control components.
• Modify and integrate existing machinery, systems and process improvement to improve quality, increase throughput, decrease costs, and strengthen safety measures.
• Modify and generate PLC programs.
• Oversee Machine Shop operations, including supervision of the Machinist.
• Supervise the PLC Engineer and Junior Mechanical Engineer.
• Provide technical guidance within the Engineering and Operations departments.
• Provide technical and mechanical support for Production operations.
• Support new company initiatives in the areas of Manufacturing and Operations.
• As part of the Change Control process, develop and control product documentation (e.g. BOMs, routings, drawings, artwork, and specifications) using Sage 100 ERP and EtQ Reliance systems.
• Write test protocols, reports and documents related to new processes.
• Ensure compliance with GMP, QSR/ISO, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.
• Regular attendance.
• Adhere to company safety requirements.

Minimum Requirements

MINIMUM REQUIREMENTS:

• Bachelor’s degree in Mechanical or Electrical Engineering.
• 5 or more years experience in Engineering, with automation background.
• Prior supervisory experience.
• Experience in a FDA manufacturing facility preferred.
• Knowledge of GMP regulations preferred.
• SolidWorks design experience.
• Knowledge of PLCs, continuous improvement principles, and sound safety practices.
• Experience with AB & Siemens PLC’s preferred.
• Electrical wiring experience preferred.
• Technical writing experience 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 with Microsoft Office products including Word, Excel, Visio and Project.

PHYSICAL REQUIREMENTS:

• Frequently required to talk and hear.
• Frequently required to sit.
• Frequently required to walk and stand.
• Frequently required to bend at waist and knees.
• Occasionally required to crouch or kneel to get under machines.
• 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.
• Fine motor control to grasp and manipulate objects.

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

• Design and develop innovative new packaging products, including material testing, preparation of specifications, and documentation.
• Create and disclose new products internally, ensuring alignment with both market strategies and manufacturing capabilities. 
• 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. 
• Schedule and manage third-party contractors, ensuring compliance with all company policies and procedures, and regulatory requirements. 
• Identify and implement necessary documentation for compliance and interact with Quality Assurance to ensure 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. 
• Lead continous 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 
• Regular attendance
• Other duties as assigned. 

Minimum Requirements

• Bachelor’s degree in Mechanical Engineering, or a related field, or an equivalent combination of education and experience
• 3-5 years manufacturing experience
• Five or more years’ experience with plastics preferred.
• Experience with blow molding and SolidWorks preferred.
• Demonstrated ability to lead people and get results through others
• Ability to work independently with minimal supervision
• Strong mechanical aptitude and working knowledge of electrical and mechanical systems
• Ability to manage several projects at once to meet established timelines is essential.
• Prior experience in FDA manufacturing facility and GMP regulations preferred

Physical Requirements

• Frequently required to talk and hear.
• Frequently required to sit.
• Frequently required to stand and walk for long periods, as work requires.
• Occasionally required to bend at waist and knees.
• Regularly lift and/or move up to 25 pounds, occasionally required to lift up to 50 pounds.
• Vision ability including close vision, distance vision, color vision and the ability to adjust focus.

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

• 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

• 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

• Plans and communicate pre-production activities to ensure production runs on-time to schedule.
• Plans and organizes the operations post-production activities to meet the scheduled milestones.
• Works cross-functionally (Planning, Production, Finance, Quality, etc) to assist in establishing easily assessable data for established metrics and measures. 
• Update as needed, daily, weekly, monthly, quarterly and yearly metrics to maintain visibility to ensure a data driven culture is well established and maintained. 
• Maintains data entry requirements by following data basic techniques and procedures. 
• Promotes and follows policies and procedures; reporting and suggesting needed changes. 
• Contributes to team effort by accomplishing other related duties as required including standard and non-standard documentation development and organization of execution. 
• Assist with maintaining balancing inventory, resources and capacity. 
• Participates in Change Control Board (CCB) activity to ensure engineering changes are consistent with the production plans and inventories.
• Assist with developing and maintaining planning bills of material and planning databases by working closely with the Master Scheduler. 
• Coordinating production workflow for one or multiple products.
• Ensure compliance with GMP, QSR/ISO, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.
• Regular attendance is an essential function of this position.
• Ability to travel by car to support multiple facility organization.
• Other duties as assigned.

Minimum Requirements

• High school or GED
• Proficient to Advanced Word, Excel, PowerPoint and data entry skills.
• Attention to detail and thoroughness
• Confidentiality
• 1-2 years relevant experience. 
• Ability to write reports, business correspondence, and procedures. 
• Ability to define problems, collect data, establish facts, and draw valid conclusions. 
• Report writing experience.
• Ability to work independently and with a team. 
• Excellent project and time management skills. 
• Experience in a FDA regulated facility preferred. 
• Knowledge of GMP regulations preferred. 

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 25 pounds
• Vision ability including close vision, distance vision, color vision, and the ability to adjust focus. 

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

Essential Responsibilities

• Perform in-process and final quality inspections of product on an as-needed basis.

• Perform incoming materials inspection of customer supplied product and raw materials.

• Interpret and execute Standard Operating Procedures (SOPs) and Work Instructions.

• Create LIMS monographs and receiving specifications.

• Release receiving materials.

• Communicate with program management for product related issues.

• Communicate with lab personnel to ensure timely test completion.

• Work directly with Batch Record Reviewer and Master Scheduler to ensure timely completion of material release.

• Provide monthly metrics for receiving inspection and releases to the Quality Manager.

• Prepare quality documentation, ensuring accuracy and completeness for all products.

• Audit the receiving documentation and warehouse.

• Ensure compliance with GMP, FDA, OSHA and all other regulatory requirements, in accordance with company policy.

• Adhere to company safety requirements.

• Regular attendance as per company policy.

• Other duties as assigned.

Minimum Requirements

• High school diploma or equivalent.

• One year experience as a quality technician or experience in a similar industry/position.

• College level coursework in Chemistry or Biology preferred.

• Knowledge of chemical terminology and units of measure.

• Awareness of scientific methodology, basic statistical understanding.

• Ability to perform and understand aseptic technique in pulling some samples is required.

• Experience in a FDA regulated manufacturing environment.

• Knowledge of GMP regulations.

• Proficient with Microsoft Office, including Word and Excel.

• Ability to follow written and oral direction.

• Ability to work independently with little direction.

• Ability to read and interpret written policies and procedures.

• Ability to complete paperwork accurately.

• Good verbal communication skills.

• Ability to work with others to achieve goals.

• Excellent attention to detail.

• Ability to recognize good quality and perform to quality standards.

• Ability to work without supervision.

PHYSICAL REQUIREMENTS:

• Frequently required to talk or hear.

• Frequently required to sit, walk, and stand.

• Occasionally lift and/or move up to 50 pounds.

• Good manual dexterity.

• Ability to grasp small objects.

• Vision includes close vision, color vision and distance vision.

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.