Job Description
Manufacturing Associates (Levels I, II, and III) for a Drug Product Team, specializing in the aseptic filling and packaging of biologic products in a controlled, cGMP-compliant environment. Manufacturing Associates will play a critical role in ensuring the successful production of sterile drug products by performing operations that include material preparation, aseptic filling, equipment setup, and final packaging.
Key Responsibilities- Manufacturing Associate I : Support routine aseptic filling and packaging operations, assist with equipment setup and cleaning, monitor quality through visual inspections, and document activities following SOPs.
- Manufacturing Associate II : Independently execute and monitor aseptic processes, lead equipment setup and minor maintenance, ensure documentation accuracy, and mentor junior associates.
- Manufacturing Associate III : Lead and oversee aseptic operations, resolve technical and operational challenges, drive process improvements, and train team members while supporting audits and validation activities.
- Level I : High school diploma or equivalent; 01 year of GMP experience; knowledge of aseptic techniques is a plus.
- Level II : Associate/Bachelor's degree preferred; 13 years of aseptic GMP experience; proficiency with sterile equipment.
- Level III : Bachelor's degree preferred; 3+ years in aseptic manufacturing with leadership experience and expertise in GMP compliance.
Key skill Required
- Manufacturing
- Cleaning
- Compliance
- Documentation
- Leadership
- Maintenance
- Packaging
- Validation
