Niir Project Consultancy Services
Website:
niir.org
Job details:
We are looking for an experienced Technical Project Engineer / Consultant specializing in Intravenous (IV) Fluids Manufacturing Plants to support the planning, designing, establishment, installation, and commissioning of IV fluids manufacturing facilities in India or abroad. The candidate should have practical knowledge of large-volume parenterals (LVP), sterile liquid manufacturing, aseptic processing, filling and sealing systems, terminal sterilization, and pharmaceutical plant utilities.
The role involves providing technical expertise throughout the project lifecycle, ensuring compliance with applicable pharmaceutical manufacturing standards, revised Schedule M, WHO-GMP requirements, and other relevant regulatory guidelines.
Key Responsibilities
- Plan and coordinate the establishment of IV fluids manufacturing plants for products such as Normal Saline (0.9% Sodium Chloride), Dextrose Solutions, Ringer’s Lactate, and other intravenous infusion solutions.
- Develop and review plant layouts, manufacturing process flow diagrams, equipment specifications, and production capacity requirements.
- Select and coordinate the procurement of IV fluids manufacturing machinery, including solution preparation tanks, mixing vessels, filtration systems, bottle or bag filling lines, sealing systems, and packaging equipment.
- Supervise machinery installation, erection, commissioning, trial runs, and production line integration.
- Coordinate the setup of sterile manufacturing areas, cleanrooms, HVAC systems, purified water systems, Water for Injection (WFI), and other critical pharmaceutical utilities.
- Provide technical guidance on IV solution preparation, filtration, filling, container closure integrity, terminal sterilization, and applicable in-process controls.
- Coordinate with machinery manufacturers, EPC contractors, architects, utility system suppliers, and pharmaceutical regulatory consultants.
- Support equipment qualification, process validation, cleaning validation, sterilization validation, and preparation of technical documentation, as applicable.
- Assist in establishing quality control and microbiological testing facilities for IV fluids manufacturing.
- Ensure compliance with applicable GMP requirements, revised Schedule M, WHO-GMP guidelines, and relevant Indian pharmaceutical regulations.
- Troubleshoot technical issues during installation, commissioning, validation, and initial commercial production.
- Support project planning, cost estimation, machinery selection, implementation schedules, and budget control.
Required Qualifications and Experience
- Bachelor’s degree in Chemical, Mechanical, Pharmaceutical, or related Engineering, or another relevant pharmaceutical qualification.
- 3–8 years of relevant experience in IV fluids, large-volume parenterals (LVP), sterile injectable manufacturing, or pharmaceutical plant project execution.
- Practical experience in IV fluids manufacturing processes, solution preparation, filling, sealing, sterilization, and packaging.
- Knowledge of cleanroom design, HVAC systems, purified water, WFI systems, and other pharmaceutical utilities.
- Familiarity with revised Schedule M, WHO-GMP, GMP documentation, equipment qualification, and process validation.
- Experience in machinery installation, plant commissioning, production troubleshooting, and technical project coordination.
- Previous involvement in setting up or expanding an IV fluids manufacturing plant will be highly preferred.
- Experience with pharmaceutical EPC projects, plant engineering, or technical consultancy will be an added advantage.
Preferred Candidate Profile
The ideal candidate should have hands-on experience in the design, installation, commissioning, or operation of an IV fluids manufacturing plant, rather than only general pharmaceutical production experience. Candidates who have successfully executed IV fluids or LVP plant projects will receive preference.
How to Apply
Interested candidates and consultants with relevant IV fluids manufacturing or plant commissioning experience are requested to share their updated resume and contact details.
Contact Person: Mr. Kumar
Email: response.npcs@gmail.com
Phone: 9811043595
Click on Apply to know more.