Job Description
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
QUALIFICATIONS
- ITI / Diploma / B.Sc / B.Pharm with 38 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.
About Us
Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.
