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Process Engineer - C&Q

Job Description - Process Engineer - C&Q

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.
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