BioProcess Engineer I/II/III (Downstream) AM

Role Summary

A Bioprocess Engineer Downstream/Fill-Finish plays a critical role in the manufacturing operations at a plant or site. This position is pivotal in ensuring the smooth execution of production processes, organizing and running operations effectively, and continuously improving the manufacturing workflow.

Responsibilities

• Performs commercial and clinical manufacturing operations on-site, including purification (downstream), fill-finish (drug product, visual inspection, packaging), media/buffer preparation, and any additional supporting activities.
• Troubleshoot equipment, collaborate with other business units to aid in manufacturing-led deviations, standardize equipment, and clean production areas.
• Assists in identifying root causes, implementing solutions, and verifying the effectiveness of those solutions.
• Contributes to the creation and ongoing maintenance of all pertinent equipment policies and procedures.
• Acquires and applies aseptic techniques relevant to cell culture, recovery, purification, aseptic fill/finish (upstream and downstream).
• Supports product requirements to ensure that all products are manufactured according to plan. Learns cGMP and cGDP protocols, ensures accurate completion of cGMP documentation, maintains current training, and adheres to all quality standards.
• Maintains quality standards to meet cGMP requirements, CFRs, and internal company policies directly related to the manufacturing process.
• Collaborates with the Quality department to ensure a compliant manufacturing environment

Qualifications

• The level of the role will be determined by the years of relevant experience.
• For Bioprocess Engineer I - Bachelor of Science Degree in Biology, Chemistry, Biotechnology or applicable field or 2 years equivalent experience.
• For Bioprocess Engineer II - Bachelor of Science Degree in Biology, Chemistry, Biotechnology or applicable field and 2 years’ experience in cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish environment; OR four (4) years’ experience in cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish environment in lieu of degree.
• For Bioprocess Engineer III - Bachelor of Science Degree in Biology, Chemistry, Biotechnology or applicable field and 4 years’ experience in cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish environment; OR six (6) years’ experience in cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish environment in lieu of degree.
• Excellent oral and written communication skills
• Near vision performance should be the equivalent of 20/20 with no impairment of color vision. The use of corrective lenses to achieve the desired visual acuity is permitted.