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Process Engineer-C&Q (Pharmaceutical Manufacturing Operations) at Unison Group

Kuala Lumpur, Kuala Lumpur, Malaysia -

Full Time

Start Date

Immediate

Expiry Date

31 Dec, 25

Salary

0.0

Posted On

02 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Process Engineering, C&Q Execution, Qualification Protocols, FAT/SAT Activities, Commissioning, Troubleshooting, DeltaV, GMP Compliance, Regulatory Requirements, Collaboration, Risk Assessments, Documentation, Pharmaceutical Manufacturing, Batch Execution, Operational Input

Industry

Business Consulting and Services

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. · 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.

Responsibilities

Support C&Q execution for process equipment and manufacturing systems, ensuring adherence to GMP and regulatory requirements. Collaborate with operations, QA, and automation teams to meet project deliverables and provide operational input during commissioning and troubleshooting.