Fill/Finish Associate (Internal Fill/Finish MFG)

When & where

• We offer multiple shifts that are 4 working days (10 hours) to support 24/7 production
• Location: Rensselaer, New York, United States
• Occasional flexibility may be requested for on-call schedule/weekend work

What you'll do

• 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; and 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.
• Maintain gowning qualification, adhere to aseptic/cleanroom behaviors, and perform environmental monitoring and sampling as required.
• 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.

The environment and physical rhythms of the role

• Gowning: 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

Let's find out if we're a fit

• HS diploma/ GED
• Or AS, BS or BA in Life Sciences or related field
• Level is determined on qualifications relevant to the role.