Process Development Engineer Category Biotech/pharmaceutical Location Dorado, Pr

Weil Group Inc

Dorado, PR
On-site
Fda-regulated medical device experience
21 cfr part 820 gmp iso 13485 knowledge
Doe pfmea risk analysis proficiency
Weil Group Inc is seeking a Process Development Engineer to support the development, validation, and implementation of new manufacturing processes in an FDA-regulated environment. The ideal candidate will have extensive experience in manufacturing and quality engineering, particularly within the biotech and pharmaceutical sectors

Job Summary

  • The role supports the development, validation, and implementation of new manufacturing processes for biotech and pharmaceutical applications.
  • Candidates must apply Design of Experiments (DOE) and Failure Mode and Effects Analysis (PFMEA) to characterize and optimize manufacturing processes.
  • The position requires strong documentation discipline and compliance with FDA regulations including 21 CFR Part 820 and ISO 13485.

Matching Summary

Match Score: 85

Weil Group Inc is seeking a Process Development Engineer to support the development, validation, and implementation of new manufacturing processes in an FDA-regulated environment. The ideal candidate will have extensive experience in manufacturing and quality engineering, particularly within the biotech and pharmaceutical sectors.

Skills & Requirements

Must-have

  • FDA-regulated medical device experience
  • 21 CFR Part 820 GMP ISO 13485 knowledge
  • DOE PFMEA risk analysis proficiency
  • Equipment qualification IQ OQ PQ support
  • Automation controls PLC servo pneumatic skills

Nice-to-have

  • Cross-functional technical collaboration
  • New product introduction scale-up experience
  • Commitment to patient safety culture

Key Requirements

  • 5-7+ years manufacturing or quality engineering experience
  • Electrical and mechanical engineering background
  • Experience with automated manufacturing systems

Work Rights

Not specified

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