Bioprocess Engineer Downstream; PM Shift

Role Summary

This on-site role is located in Durham, NC and cannot be performed remotely. The Bio Process 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.

• 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.

• 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.

• Bioprocess Engineer II:
  Bachelor of Science Degree in Biology,…