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Senior C&Q Engineer - Device Assembly and Packaging

BioPharma Consulting JAD Group
•Onsite
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About The Position

Lead commissioning and qualification (C&Q) for device assembly and packaging equipment at a biotechnology company in Juncos, Puerto Rico. The role covers the C&Q strategy through characterization reports and includes overseeing equipment testing and commissioning, preparing and executing qualification documentation, managing validated-system changes and CAPAs, and mentoring junior engineers.

Requirements

  • Bachelor's degree in Engineering and 4 years of experience, or a Master's degree and 2 years of experience, or a PhD.
  • C&Q experience with full validation-lifecycle documentation.
  • Knowledge of GMP, ALCOA+, and electronic document systems.

Nice To Haves

  • Experience with device assembly, packaging, or vision systems.

Responsibilities

  • Develop the C&Q strategy, system boundaries, and risk assessments using ISPE Baseline and ASTM E2500.
  • Oversee factory acceptance testing (FAT), site acceptance testing (SAT), and field commissioning.
  • Author IQ/OQ/PQ documentation with URS traceability.
  • Write and execute characterization protocols and reports.
  • Manage change controls and CAPAs for validated systems.
  • Mentor junior engineers.

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What This Job Offers

Career Level

Senior

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