Responsibilities:
We are seeking an experienced Technical Production / Project Engineer / Consultant to support the planning, establishment, installation, and commissioning of an IV Fluids and Pharmaceutical Manufacturing Plant. The candidate will be responsible for providing technical expertise throughout the project, ensuring compliance with applicable pharmaceutical manufacturing standards and regulatory requirements.
- Plan and coordinate the setup of IV fluids and pharmaceutical manufacturing facilities.
- Develop and review plant layouts, process flow diagrams, equipment specifications, and utility requirements.
- Coordinate machinery selection, procurement, installation, erection, and commissioning.
- Oversee the installation of manufacturing, filling, sterilization, packaging, and quality control systems.
- Ensure compliance with applicable WHO-GMP, Schedule M, and other relevant regulatory requirements.
- Guide the implementation of cleanroom facilities, HVAC systems, water for injection (WFI), purified water, and other critical utilities, as applicable.
- Coordinate with machinery suppliers, contractors, architects, and regulatory consultants.
- Support process validation, documentation, troubleshooting, and initial production activities.
- Ensure project execution within the approved timelines, budget, quality, and safety standards.
Key Skills:
- Bachelor’s degree in Chemical, Mechanical, Pharmaceutical, or related Engineering; relevant pharmaceutical qualifications will also be considered.
- 3–8 years of relevant experience in pharmaceutical plant setup, IV fluids manufacturing, production, or project commissioning.
- Practical knowledge of IV fluids manufacturing processes, aseptic filling, sterilization, cleanrooms, and pharmaceutical utilities.
- Familiarity with WHO-GMP, revised Schedule M, quality systems, and pharmaceutical regulatory compliance.
- Experience in machinery installation, plant commissioning, process validation, and technical documentation.
- Strong project coordination, troubleshooting, and problem-solving skills.
- Experience in EPC projects or pharmaceutical plant consultancy will be an advantage.
Contact Details
Person: Mr. Kumar
Email: response.npcs@gmail.com
Phone: 9811043595
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