The Process Engineer will support commissioning and qualification activities, review and execute protocols, and collaborate with various teams to ensure systems meet GMP standards.
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.
Top Skills
Deltav
Unison Consulting Singapore Office
1 Changi Business Park Crescent, , Plaza 8 #03-06 Tower A, Singapore, , Singapore, 486025
Unison Consulting Singapore Office
#12-00, 63 Market Street, Bank of Singapore Center, Singapore, , Singapore, 048942
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