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About the role
Key responsibilities & impact- Provide primary engineering support for all Packaging, visual inspection, and support Packaging line and product transfers
- Support Packaging startup and commissioning activities
- Use GMP industry best practices to measure, analyze and specify requirements that lead to best-in-class quality products and design for manufacturability
- Act as Packaging system owner during start up activities
- Lead and support Packaging implementation and improvements
- Support the implementation and use of PAS-X
- Support generation, review, and approval of Packaging SOPs
- Support deviations/change controls associated with Packaging line and product transfers
- Lead projects relating to the development and optimization of Packaging processes
- Evaluate existing Packaging processes for improvements in capacity, efficiency, and product quality in alignment with business needs
- Improve testing methods and quality control measures, incoming materials, standards, and controls
- Develop user requirements for new capital equipment, survey potential equipment suppliers, submit RFQs, evaluate proposals from suppliers, and provide recommendations for purchase
- Develop and execute test protocols and reports to validate new or modified processes
- Investigate root causes of Packaging issues impacting product quality or yield and support implementation of improvements
Requirements
What you’ll need- BS in an Engineering discipline
- 6+ years of experience
- Food and Drug Administration, USDA, and/or work in a regulated manufacturing environment, preferably in aseptic manufacturing or Packaging, or medical device industry
- Proven experience in the application of engineering principles to the design and improvement of manufacturing processes
- Experience working with GMP contract manufacturing organizations and third-party suppliers
- Experience with pharmaceutical equipment and test method validation preferred
- Experience with Operational Excellence tools such as DMAIC, 5 WHY’s, Fishbones, FMEA, etc.
- Green belt or Black belt certification is a plus
- Proficient computer skills such as PAS-X or electronics batch record (EBR/MES), Excel, Word, MS Visio, JMP, Minitab, SAP, or similar software
Benefits
Comp & perks- Healthcare
- Dental coverage
- Retirement savings benefits
- Paid holidays
- Vacation
- Disability insurance
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Engineering PrinciplesManufacturing Process ImprovementQuality Control MeasuresRoot Cause AnalysisTest Protocol Development
Soft Skills
Project LeadershipAnalytical ThinkingCollaboration
Certifications
Green Belt CertificationBlack Belt Certification
