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Process Engineer-C&Q (Pharmaceutical Manufacturing Operations)
Unison Group
Kuala Lumpur, Federal Territory of Kuala Lumpur, MY
1 hari lalu
Jenis pekerjaan
Quick Apply
Penerangan pekerjaan
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
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