Bioprocess Engineer Downstream (PM Shift)

Role Summary

This on-site role is located in Durham, NC and cannot be performed remotely. The BioProcess Engineer will support drug product manufacturing activities including fill-finish, visual inspection, packaging, and media and buffer preparation, ensuring GMP-compliant, safe, and consistent production. You will troubleshoot equipment, support deviations, and contribute to root-cause analysis and continuous improvement, partnering with Quality and Operations to maintain an inspection-ready operation that delivers robust drug product processes for patients. The role operates on a 2-2-3 PM shift with approximate hours from 5:45 PM to 6:15 AM.

Responsibilities

• Execute commercial and clinical drug product manufacturing, including fill-finish, visual inspection, packaging, and buffer preparation.
• Operate and monitor manufacturing equipment to ensure safe, efficient, and compliant drug product production.
• Troubleshoot equipment and process issues, escalating and collaborating cross-functionally to minimize production impact.
• Support manufacturing-led deviations, contributing to root cause analysis and effective corrective and preventive actions.
• Apply and maintain strong aseptic techniques during all drug product manufacturing activities.
• Ensure strict adherence to current Good Manufacturing Practice standards, standard operating procedures, and documentation requirements.
• Accurately complete batch records and manufacturing documentation to support inspection-ready operations.
• Maintain clean and organized production areas in alignment with safety and quality standards.
• Partner closely with Quality to sustain a compliant manufacturing environment and support audits or inspections.
• Contribute to continuous improvement initiatives that strengthen drug product processes, reliability, and efficiency.

Qualifications

• Required: The level of the role will be determined by the years of relevant experience.
• Required: 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.
• Required: 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.
• Required: Hands-on experience supporting drug product manufacturing, including fill-finish operations, inspection, or packaging activities.
• Required: Strong understanding of aseptic manufacturing principles and disciplined execution in controlled production environments.
• Required: Demonstrated ability to troubleshoot equipment and process issues and support manufacturing-led deviation investigations.
• Required: Experience completing accurate manufacturing documentation and maintaining compliance with standard operating procedures and quality standards.
• Required: Effective written and verbal communication skills, with the ability to collaborate across Operations, Quality, and technical teams.
• Required: 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.
• Preferred: Familiarity with isolators and advanced aseptic processing concepts used in modern drug product manufacturing.

Education

• 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.
• 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.