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Open nowPosted 46 hours ago

Senior C&Q Engineer - Device Assembly and Packaging

BioPharma Consulting JAD Group

Where
Juncos, Puerto Rico
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Your applicationOpen nowSenior C&Q Engineer - Device Assembly and PackagingBioPharma Consulting JAD Group · Juncos, Puerto Rico

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  5. 35.6%30 days
  6. 58.1%60 days
This job: posted 46 hours ago

The posting

Lead commissioning and qualification for device assembly and packaging equipment at a leading biotechnology company in Juncos, Puerto Rico, from the C&Q strategy through the characterization reports.

What you'll do

  • Build the C&Q strategy, system boundaries and risk assessments (ISPE Baseline, ASTM E2500).
  • Oversee FAT/SAT and field commissioning; author IQ/OQ/PQ with URS traceability.
  • Write and execute characterization protocols and reports.
  • Manage change controls and CAPAs on validated systems; mentor junior engineers.

Requirements

  • Bachelor's degree in Engineering + 4 years (or Master's + 2, or PhD).
  • C&Q with full validation-lifecycle documentation.
  • GMP, ALCOA+, electronic document systems.
  • Device assembly, packaging or vision systems are a strong plus.

Benefits

  • Contract: 6 months, with possible extension
  • Shift: Administrative, Monday–Friday
  • Start: Immediate
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