19 Oct
|
Niir Project Consultancy Services
|
India
19 Oct
Niir Project Consultancy Services
India
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,
📌 IV Fluids Manufacturing Plant – Technical Project Consultant (India)
🏢 Niir Project Consultancy Services
📍 India