Bioprocess Engineer Downstream; PM Shift

Job Description Summary

#LI-Onsite

This position will be located on-site in Durham, NC and will not have the ability to be located remotely. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

Join a Drug Product-focused manufacturing team where attention to detail, aseptic discipline, and patient impact are central to the work you do. As a Bio Process Engineer, you'll support fill finish operations, visual inspection, packaging, and media and buffer preparation, helping ensure drug product is manufactured safely, consistently, and in full alignment with current Good Manufacturing Practice requirements. You'll apply handson experience from regulated manufacturing environments to troubleshoot equipment, support manufacturing led deviations, and contribute to effective root cause analysis and continuous improvement.

Partnering closely with Quality and Operations, you'll help maintain a compliant, inspection ready operation while strengthening robust drug product processes that patients can trust.

• 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.

Shift: The shift for this role operates on a 2-2-3 PM Shift schedule. Approximate start/end times are 5:45pm - 6:15am.

• 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
• Handson experience supporting drug product manufacturing, including fill finish operations, inspection, or packaging activities.
• Strong understanding of aseptic manufacturing principles and disciplined execution in controlled production environments.
• Demonstrated ability to troubleshoot equipment and process issues and support manufacturing led deviation investigations.
• Experience completing accurate manufacturing documentation and maintaining compliance with standard operating procedures and quality standards.
• Effective written and verbal communication skills, with the ability to collaborate across Operations, Quality, and technical teams.
• 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.

• Familiarity with isolators and advanced aseptic processing concepts used in modern drug product manufacturing.

The salary for this position is expected to range between $32.12 and $59.62, per hour.

The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically.

Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role,…