Manufacturing Operator

Manufacturing Associate (II-III) Aseptic Biologics | Chicago Relocation Opportunity

Please ensure you read the below overview and requirements for this employment opportunity completely.

We're supporting a rapidly expanding biologics manufacturer through the next phase of its Chicago build-out, with continued investment across manufacturing capability, infrastructure and talent. As part of this expansion, we are seeking several experienced Manufacturing Associates to join the Drug Product Manufacturing team supporting aseptic fill-finish operations.

This is a hands-on manufacturing position working across formulation, filtration and aseptic filling of drug products for clinical and commercial use. You'll operate within controlled and classified cleanroom environments, supporting cGMP manufacturing from material preparation through formulation, filtration and filling.

The position requires genuine hands-on experience within aseptic pharmaceutical or biologics manufacturing and would suit someone comfortable working on the manufacturing floor, operating equipment and executing batches within a highly regulated GMP environment.

Responsibilities:

• Support formulation, filtration and aseptic filling activities for Drug Product manufacturing.
• Operate equipment including syringe filling systems, autoclaves, parts washers, filter integrity testers, mixing systems and peristaltic pumps.
• Perform equipment assembly, cleaning, sterilization and operation.
• Execute line clearance and inspection activities across ISO 6, ISO 7 and ISO 8 classified areas.
• Perform aseptic filling activities while maintaining strong aseptic technique and cleanroom behaviour.
• Support material weighing and dispensing and the preparation of media and buffer solutions.
• Perform filter integrity testing and in-process testing including pH and conductivity.
• Support environmental and personnel monitoring activities.
• Complete batch records and associated cGMP documentation accurately and on time.
• Support equipment/process troubleshooting and report manufacturing events or non-conformances.
• Assist with technology transfer activities from Process Development into cGMP Manufacturing.
• Support and train junior Manufacturing Associates where required.

Qualifications

• 5+ years of relevant pharmaceutical, biotechnology or biologics manufacturing experience
• Hands-on experience within aseptic filling and cleanroom manufacturing is required.
• Experience operating equipment such as autoclaves, filling machines, filtration systems, peristaltic pumps or similar Drug Product equipment.
• Strong understanding of cGMP manufacturing, SOPs and controlled documentation.
• Experience completing batch records and working within established GMP procedures.
• Comfortable operating complex manufacturing equipment with limited supervision.

Please Note: These are full-time, on-site roles based in Chicago City. xhyhwjd

Relocation assistance is available , and we welcome applications from candidates across the U.S. who are open to relocating.