Manufacturing Operator

Global Life Science Hub; United States; On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Global Life Science Hub seeks Manufacturing Associate (II-III) for on-site work in Chicago, supporting aseptic fill-finish operations in a regulated GMP environment. You will work across formulation, filtration and aseptic filling in controlled cleanroom spaces for clinical and commercial use.

Requires 5+ years in pharmaceutical/biologics manufacturing with hands-on aseptic filling, GMP documentation, and equipment operation.

Qualifications

• 5+ years of relevant pharmaceutical or biologics manufacturing experience.
• Hands-on aseptic filling and cleanroom manufacturing experience.
• Experience operating autoclaves, filling machines and filtration systems.
• Strong knowledge of cGMP, SOPs, and documentation.
• Experience completing batch records in GMP environments.

Responsibilities

• Support formulation, filtration and aseptic filling activities.
• 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.

Skills

Aseptic filling

Cleanroom manufacturing

GMP / cGMP

Equipment operation

Batch records

Documentation

Tools

Autoclaves

Filtration systems

Syringe filling systems

Peristaltic pumps

Mixing systems

Job description

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

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.

Please Note:

These are full-time, on-site roles based in Chicago City.

• 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.

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