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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Packaging Engineering, focusing on process optimization, quality control, and compliance with GMP standards. Proficient in leading projects that enhance manufacturing efficiency and product quality in regulated environments.
Highest-signal resume keywords
Packaging Process OptimizationGMP CompliancePAS-X ImplementationTest Method ValidationOperational Excellence Tools
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Engineering PrinciplesManufacturing Process ImprovementQuality Control MeasuresRoot Cause AnalysisTest Protocol Development
Soft Skills
Project LeadershipAnalytical ThinkingCollaboration
Tools & Technologies
PAS-XExcelMS WordMS VisioJMPMinitabSAP
Certifications & Qualifications
Green Belt CertificationBlack Belt Certification
Industry Keywords
GMPFDAUSDAAseptic ManufacturingMedical Device Industry
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