Job Title

Officer / Executive – Sterile Formulation & Filling Department:

Production / Operations (Injectable Line) Experience Required:

3 to 7 Years in Sterile Injectables or Biologics/Vaccine Manufacturing Education:

B.Pharm / M.Pharm / B.Tech (Biotechnology) / M.Sc. (Microbiology/Biotech)

Key Responsibilities includes: Line Supervision:

Supervise real-time filling operations inside the Grade A Isolator core. Monitor parameters across check-weighers, line speeds, and robotic nest pickup functions via the integrated IPC SCADA systems.

Regulatory Compliance & Data Integrity:

Ensure complete shift compliance with US FDA 21 CFR Part 11..

Validation & Aseptic Processing Support:

Participate directly in and supervise the execution of equipment qualification / validation and Aseptic Process Simulations (APS / Media Fills), energetic smoke profiling studies, and HEPA filter leak assessments (PAO challenge testing).

Documentation

Prepare and Review of SOP , Protocol , report and other QMS elements.

Technical Competencies Deep operational expertise in supervising formulation and filling operations. Well-versed in troubleshooting filling machine , isolator Have strong hands on isolator technology and aseptic practices.

📌 Supervisor (Officer / Executive) – Vaccine Production (Navi Mumbai)
🏢 TechInvention Lifecare
📍 Navi Mumbai