Assistant Manager, Manufacturing Injectables

Greenfield Project Execution:

• Assist in installation, commissioning, and qualification (IQ/OQ/PQ) of Optima PFS filling line, isolators, and associated equipment.
• Participate in CSPE (Comprehensive Scientific Process Engineering) activities to ensure smooth and timely production startup
• Support validation and engineering teams during FAT/SAT and process simulations.

Routine Operations:

• Operate Optima PFS filling systems for ready-to-use (RTU) syringes in nested tubs, ensuring sterile and accurate filling
• Perform de-bagging, Tyvek® film removal, filling, closing, and secondary processing steps such as labeling and safety device assembly.
• Monitor in-process controls (IPC) including fill volume, stopper height, and container integrity using systems like SIRM (Syringe Inspection and Reject Machine)
• Ensure isolator integrity and aseptic conditions throughout the production cycle.

Compliance & Documentation:

• Maintain accurate batch records, logbooks, and equipment usage documentation.
• Adhere strictly to cGMP, Annex 1, and USFDA guidelines for sterile manufacturing.
• Support internal audits and regulatory inspections with proper documentation and operational readiness.

Qualifications:

• ITI / Diploma / B.Sc / B.Pharm with 3–8 years of experience in sterile injectable operations.
• Prior experience with
• PFS filling lines in isolator-based setups.
Familiarity with aseptic techniques, cleanroom protocols, and IPC systems.

Preferred Skills:

• Experience in greenfield project execution or facility startup.
• Knowledge of IPAS (Intelligent Production Assistance Services) for digital monitoring and troubleshooting
• Ability to work in a high-speed, high-precision environment with minimal supervision.
• Strong documentation and communication skills.