Process Engineer - C&Q

Unison Consulting Pte Ltd; Singapore; On-site; SGD 60,000 - 80,000; Full time

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

Manufacturing operations knowledge

DeltaV expertise

Collaboration skills

GMP knowledge

Education

Bachelor’s degree in Engineering

Tools

DeltaV

Job description

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.