Senior Pharmaceutical Process Engineer
2 days ago
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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