BioProcess Engineer I/II
Listed on 2026-07-20
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Manufacturing / Production
Production QC/QA, Validation Engineer
Location
Durham, NC. Onsite role. Novartis cannot offer relocation support. Please only apply if the location is accessible.
ShiftRotating 2‑2‑3 night shift (5:45pm – 6:15am).
Key Responsibilities- Execute hands‑on drug product manufacturing across fill‑finish, inspection, packaging, and media and buffer preparation.
- Operate, monitor, and adjust manufacturing equipment to ensure safe, efficient, and compliant production.
- Troubleshoot equipment and process issues, escalating and collaborating to minimize production impact.
- Apply and maintain strong aseptic techniques in controlled manufacturing environments.
- Support manufacturing‑led deviations, 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.
- For Bioprocess Engineer I:
Bachelor of Science degree in Biology, Chemistry, Biotechnology, or a related field, or equivalent relevant experience. - For Bioprocess Engineer II:
Bachelor of Science degree in Biology, Chemistry, Biotechnology or applicable field and 2years’ experience in cGMP or equivalent relevant experience. - Hands‑on experience working in a regulated manufacturing or current Good Manufacturing Practice environment.
- Strong understanding of aseptic manufacturing principles and disciplined execution in controlled environments.
- Ability to troubleshoot equipment and process issues and support deviation investigations.
- Proven ability to accurately complete manufacturing documentation following procedures and quality standards.
- Effective written and verbal communication skills to collaborate across Operations, Quality, and technical teams.
- Near‑vision equivalent to 20/20 with no color‑vision impairment; corrective lenses permitted if needed.
Salary ranges:
Bioprocess Engineer I, $22.84–$42.46 per hour;
Bioprocess Engineer II/III, $32.12–$59.62 per hour. Final salary will be determined based on relevant skills and experience and reviewed periodically.
Compensation includes a performance‑based cash incentive and, depending on the role level, eligibility for annual equity awards.
BenefitsUS‑based eligible employees will receive a comprehensive benefits package that includes health, life, and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. Employees are eligible for a generous time‑off package including vacation, personal days, holidays, and other leaves.
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