About this role
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.
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.
Other facts
About Amneal
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) is guided by a simple belief: essential medicines should be accessible to everyone. What began as a promise to deliver high-quality, affordable medicines has evolved into a diversified portfolio spanning complex generics and injectables, biosimilars, and specialty medicines, including more than 290 products, with scale and capabilities that help reach patients across the healthcare system while combining world-class precision with a deep sense of personal responsibility for every dose we deliver.
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Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or [email protected]. If you are currently experiencing a life-threatening event, please immediately contact 911.
What you'll do
- This role involves assisting in the execution of a greenfield project, specifically supporting the installation, commissioning, and qualification of injectable manufacturing equipment like filling lines and isolators. The Deputy Manager will also be responsible for routine operations, including operating filling systems for RTU syringes while strictly monitoring in-process controls and maintaining aseptic conditions.
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