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Process Engineer-C&Q (Pharmaceutical Manufacturing Operations)

Process Engineer-C&Q (Pharmaceutical Manufacturing Operations)

Unison GroupKuala Lumpur, Kuala Lumpur, Malaysia
20 hours ago
Job description

Overview

Process Engineer-C&Q (Pharmaceutical Manufacturing Operations) – Unison Group, Kuala Lumpur, Malaysia

Location : Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia

Responsibilities

  • 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

Qualifications

  • 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

    • Employment details

  • Seniority level : Associate
  • Employment type : Full-time
  • Base pay range : SGD60,000.00 / yr - SGD72,000.00 / yr

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    Operation • Kuala Lumpur, Kuala Lumpur, Malaysia