Senior Pharmaceutical Process Engineer

2 days ago


India PQE Group Full time

About the Role

We are seeking an experienced Pharmaceutical Process Engineer to join our team in India. As a key member of our projects, you will play a crucial role in supporting our initiatives in the region.

Your Key Responsibilities

  • Evaluate and select suitable equipment for OSD and sterile manufacturing processes.
  • Perform capacity calculations, equipment selection, and sizing to meet production targets.
  • Develop plant equipment layout concepts, process flow diagrams, and P&IDs.
  • Design facility layouts that optimize workflow while adhering to regulatory requirements.
  • Prepare project design packages, including feasibility studies, Concept Design (CD), Front-End Engineering Design (FEED), and Detailed Design (DD).
  • Review and prepare qualification documents like DQ, IQ, OQ, PQ, FAT/SAT protocols, and reports.
  • Ensure compliance with CGMP regulations (USFDA, EU CGMP, WHO, UKMHRA) and EHS requirements.
  • Prepare for internal audits and regulatory inspections by maintaining complete documentation.
  • Design containment areas for potent compounds and biologics.
  • Develop waste management and contamination control strategies.
  • Troubleshoot process equipment in sterile and solid facilities.
  • Provide process input to architects and cross-functional teams.
  • Manage vendors and support manufacturing operations.
  • Conduct feasibility studies and risk analyses.

About You

  • You must have 10+ years of experience in the pharmaceutical industry or consulting.
  • Proven process engineering experience in design consultancy or GMP manufacturing is required.
  • Exposure to international projects in Europe and the U.S. is essential.
  • Expertise in OSD, sterile, and biologics formulations is necessary.
  • Strong knowledge of process calculations, safety, and regulatory compliance is required.
  • Experience preparing project documentation and plant layouts is beneficial.

What We Offer

We offer a competitive salary of $120,000 - $150,000 per annum, depending on your experience and qualifications. Our benefits package includes a generous bonus scheme, comprehensive health insurance, and opportunities for career growth and professional development.

Location and Working Arrangements

This role is based in India, with 90% remote working arrangements and periodic travel for on-site support. You will be part of a multicultural team that values collaboration and innovation.



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