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Process Engineer-C&Q (Pharmaceutical Manufacturing Operations)

Process Engineer-C&Q (Pharmaceutical Manufacturing Operations)

Unison GroupKuala Lumpur, Federal Territory of Kuala Lumpur, MY
20 hours ago
Job type
  • Quick Apply
Job description
  • Support C&Q execution for process equipment, utilities, and manufacturing systems.
  • Review and execute qualification protocols (IQ, OQ, PQ) and support FAT / SAT activities.
  • Provide process and operational input during commissioning and troubleshooting.
  • Support DeltaV-related activities (recipes, phases, batch execution understanding).
  • Develop / review C&Q documentation (URS, risk assessments, protocols, reports).
  • Ensure adherence to GMP, regulatory, and data integrity requirements.
  • Collaborate with operations, QA, and automation teams to meet project deliverables.

    • Requirements

    • Bachelor’s degree in chemical / Biochemical / Process / Mechanical Engineering or related field.
    • 4–6 years’ experience in pharmaceutical / biotech manufacturing or operations, with exposure to C&Q .
    • Strong process knowledge of pharmaceutical manufacturing.
    • Working knowledge of DeltaV – recipes, batch execution, troubleshooting.
    • Hands-on experience with C&Q documentation and execution (IQ, OQ, PQ).
    • Good knowledge of cGMP, FDA / EMA guidelines, and industry practices.
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    Operation • Kuala Lumpur, Federal Territory of Kuala Lumpur, MY