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.
Requirements
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.