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Pharmaceutical Engineering Specialist

1 week ago


Kuala Lumpur, Kuala Lumpur, Malaysia MMR Consulting Full time
Job Description

MMR Consulting is seeking a skilled Pharmaceutical Engineering Specialist to join our team.

The ideal candidate will have expertise in process control systems and commissioning, qualification, and startup of automation systems.

Responsibilities:

  • Lead the development of key qualification deliverables during the project lifecycle.
  • Ensure compliance with regulatory requirements such as GAMP 5, 21 CFR Part 11, and CSV.
  • Develop and execute IQ, OQ, and PQ protocols.
  • Coordinate meetings with cross-functional departments to drive project progress.

Qualifications:

  • Bachelor's degree in electrical, Instrumentation, or Automation Engineering.
  • 6-10 years of experience in Delta V Emerson DCS commissioning & qualification (C&Q). Experience with validation of other automation systems is an asset.
  • C&Q Expertise: Proficient in IQ, OQ, and PQ protocol development and execution.
  • Regulatory Compliance: Knowledge of GAMP 5, 21 CFR Part 11, and CSV.