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Process Engineer - C&Q
Job summary
A consulting firm in Singapore is seeking Process Engineers with 4-6 years of experience in pharmaceutical or biotech manufacturing. The role involves supporting Commissioning & Qualification activities, requiring strong knowledge of DeltaV, GMP, and relevant qualification documentation. Candidates must have a Bachelor's degree in engineering and the ability to collaborate with various teams for project deliverables.
Qualifications
- 4–6 years' experience in pharmaceutical/biotech manufacturing.
- Strong knowledge of cGMP and FDA/EMA guidelines.
- Experience with C&Q documentation and protocols.
Responsibilities
- Support C&Q execution for process equipment and manufacturing systems.
- Review and execute qualification protocols like IQ, OQ, PQ.
- Collaborate with teams for project deliverables.
Skills
Education
Tools
Role Overview:
We are looking for Process Engineers (4–6 years) with strong manufacturing operations and process knowledge to support Commissioning & Qualification (C&Q) activities. Candidates with working knowledge of DeltaV — including recipes, phases, and batch execution — will be preferred. The role involves collaborating with manufacturing, QA, and automation teams to ensure equipment and process systems are qualified and ready for GMP production.
Key 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 and 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.
* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.
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