Biologics Operator II – 3rd Shift

About the role

We are seeking a Biologics Operator II to work the 3rd shift in our manufacturing facility. The role involves producing bulk biologic products in aseptic and non‑aseptic environments, ensuring compliance with cGMP and safety standards.

Key responsibilities

• Operate manufacturing equipment such as tanks, autoclaves, filtration systems, washers, and perform filter integrity testing and pH measurements.
• Conduct equipment setup and cleaning procedures (CIP, PT, SIP) according to established SOPs.
• Perform bulk biologics operations in Media & Buffer Formulation, Inoculum/Fermentation, and Capture/Purification areas.
• Inspect equipment and facilities, monitor critical parameters, and report deviations.
• Provide technical assistance and troubleshooting for equipment and process events.
• Receive, inspect, and verify material availability for production.
• Document batch records, process status, and sample collection in electronic or paper formats.
• Adhere strictly to cGMP, SOPs, and EHS policies, including PPE use and waste management.

Required profile

• Associate Degree in Science, Mechanics, Electricity, Instrumentation or a related field.
• No prior experience required.
• Basic knowledge of laboratory techniques and computerized systems (Delta V, MES, SAP preferred).
• Basic mechanical, mathematical, verbal and written communication skills in English and Spanish.

Required skills

• Operation of tanks, autoclaves, filtration systems, washers.
• Filter integrity testing and pH measurement.
• CIP, PT and SIP equipment setup.
• Use of Delta V, MES and SAP systems.
• Understanding of cGMP and SOP compliance.