Fill/Finish Associate (Internal Fill/Finish MFG)
Regeneron
Fill/Finish Associate performs production and support duties for drug product manufacturing, maintaining formulation, filling, assembly, labeling, and cartoning/packing equipment for parenteral biological products. Works individually and in teams; develops proficiency in processes of increasing complexity.
Responsibilities (typical day):
- Produce therapeutics for various indications.
- Operate automated aseptic equipment to fill vials/syringes.
- Assemble filled drug product into syringes and autoinjectors.
- Operate packaging lines to prepare assembled/labeled product for distribution.
- Monitor production line operation using pneumatics, robotics, manual and PLC feedback systems.
- Clean, handle, and install interchangeable equipment parts.
- Collaborate to create/maintain operating procedures meeting regulatory expectations.
- Ensure clean, safe, ready working spaces/equipment.
- Maintain gowning qualification and follow cleanroom behaviors.
- Perform environmental sampling (as applicable).
- Record GMP data accurately and complete record reviews; maintain training documentation.
- Use electronic systems to support manufacturing operations.
- Ensure procedure compliance and escalate non-conformities; perform product/controlled material reconciliation (where applicable).
- Domestic/international travel may be required.
Qualifications/Skills:
- GED/High school diploma and previous work experience.
- Ability to perform basic algebra and geometry; reading/writing skills.
- Attention to detail.
- Knowledge of cGMP and FDA-regulated manufacturing environment (preferred); familiarity with cGMP filling/assembly/packaging (preferred).
- Preferred: aseptic technique; experience operating filling equipment or assembling/packaging parenteral products in vials/syringes/cartridges (manual and automated).
- Basic understanding of Microsoft Office Suite.
- Strong interpersonal/cross-cultural communication, negotiation, and problem-solving; teamwork; integrity.
- Must be able to stand up to 10 hours and lift/push/pull at least 50 lbs; perform physical tasks (bending, climbing, reaching, etc.).
- Cleanroom attire compliance; remove jewelry/makeup/nail adornments.
- Ability to remove jewelry/makeup/nail adornments when wearing cleanroom attire.
Application:
Apply now.