BioProcess Engineer I
About The Position
The BioProcess Engineer I works onsite in Durham, North Carolina, in a hands-on drug product manufacturing role. The position supports day-to-day production across fill-finish operations, visual inspection, packaging, and media and buffer preparation. It involves operating manufacturing equipment, troubleshooting process and equipment issues, applying aseptic techniques, and completing manufacturing documentation in a regulated environment. The employee works closely with Operations and Quality to support safe, compliant, and reliable production, including contributing to deviation investigations and maintaining inspection-ready production areas. The role works a rotating 2-2-3 night shift from 5:45 pm to 6:15 am. Novartis does not offer relocation support for this role.
Requirements
- Bachelor of Science degree in Biology, Chemistry, Biotechnology, or a related field, or equivalent relevant experience.
- Hands-on experience in regulated manufacturing or a current Good Manufacturing Practice (cGMP) environment.
- Strong understanding of aseptic manufacturing principles and disciplined execution in controlled environments.
- Ability to troubleshoot equipment and process issues and support deviation investigations.
- Ability to complete manufacturing documentation accurately in accordance with procedures and quality standards.
- Effective written and verbal communication skills for collaboration across Operations, Quality, and technical teams.
- Near vision equivalent to 20/20 and no color vision impairment; corrective lenses are permitted if needed.
Responsibilities
- Execute drug product manufacturing activities across fill-finish, inspection, packaging, and media and buffer preparation.
- Operate, monitor, and adjust manufacturing equipment to support safe, efficient, and compliant production.
- Troubleshoot equipment and process issues, escalating them and collaborating to minimize production impact.
- Apply and maintain aseptic techniques in controlled manufacturing environments.
- Support manufacturing-led deviations, including contributing to root cause analysis and corrective actions.
- Complete batch records and manufacturing documentation accurately and in real time.
- Partner with Quality and Operations to maintain inspection-ready, compliant production areas.
Benefits
- Performance-based cash incentive.
- Depending on role level, eligibility to be considered for annual equity awards.
- Health benefits.
- Life benefits.
- Disability benefits.
- 401(k) with company contribution and match.
- Vacation, personal days, holidays, and other leaves.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
