Fill/Finish Associate (Internal Fill/Finish MFG)

About the role

The Fill/Finish Associate performs all duties related to the production and support of drug product manufacturing. They work individually and as part of a team to support and perform operations to maintain formulation, filling, assembly, labeling and cartoning/packing equipment for parenteral biological products.

Responsibilities

• Operate highly automated aseptic filling equipment to load drug product into vials, syringes, and cartridges within isolators or other cleanroom environments;
• Assemble filled product into syringes and autoinjectors;
• Run state-of-the-art packaging lines to label and configure product for distribution;
• Monitor production operations using process controls and feedback systems (pneumatics, robotics, manual checks, and PLCs) to ensure throughput, quality, and compliance;
• Perform equipment changeovers, cleaning, handling, and installation of interchangeable parts;
• Maintain clean, safe, and inspection-ready workspaces and equipment;
• Create, follow, and improve SOPs and operating procedures aligned with cGMP and regulatory expectations; ensure compliance during execution and promptly escalate nonconformities;
• Record and review GMP data with ALCOA principles (accurate, legible, attributable, contemporaneous); reconcile product and controlled materials; and ensure complete training documentation;
• Utilize electronic systems (e.g., MES/eBR, LIMS, training systems, and Microsoft Office) to support manufacturing operations and documentation;
• Travel domestically and internationally as needed to support production or technology transfer activities.

Requirements

Operate highly automated aseptic filling equipment to load drug product into vials, syringes, and cartridges within isolators or other cleanroom environments; assemble filled product into syringes and autoinjectors; run state-of-the-art packaging lines to label and configure product for distribution.

Qualifications

• HS diploma/GED or AS, BS or BA in Life Sciences or related field.

Skills

Full cleanroom attire (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)

Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire

Ability to perform physical requirements for entirety of shift (up to 10 hours) in a clean room environment

Some physical requirements can include but not limited to: bending, climbing, crawling, kneeling, reaching, reaching overhead, sitting, squatting, walking, standing, driving, hand manipulation and ability to lift/push/pull up to 50lbs

Benefits

Student loan paydown program & tuition reimbursement

Family care benefits

Inclusion, culture and well-being programs (including physical & mental health)

Pay

Salary Range (hourly): $16.20 - $38.56

Schedule

Multiple shifts that are 4 working days (10 hours) to support 24/7 production