Job Description & How to Apply Below
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 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.
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.
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