BioProcess Engineer I
Novartis
Summary
Step directly onto the manufacturing floor and make a tangible impact on medicines that reach patients worldwide. In this hands-on role, you'll be deeply involved in day-to-day drug product manufacturing, from fill-finish operations to visual inspection and packaging, applying strong aseptic discipline and technical rigor at every step. You'll work side by side with Operations and Quality, operating equipment, troubleshooting real-time issues, and contributing to investigations that keep production safe, compliant, and reliable.
Job description
Job Description Summary
Step directly onto the manufacturing floor and make a tangible impact on medicines that reach patients worldwide. In this hands-on role, you'll be deeply involved in day-to-day drug product manufacturing, from fill-finish operations to visual inspection and packaging, applying strong aseptic discipline and technical rigor at every step. You'll work side by side with Operations and Quality, operating equipment, troubleshooting real-time issues, and contributing to investigations that keep production safe, compliant, and reliable.
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.
Essential Requirements
- Bachelor of Science degree in Biology, Chemistry, Biotechnology, or a related field, 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.
Location & Shift
- This position will be located in Durham, NC and will be an onsite role.
- Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
- This role will work on a rotating 2-2-3 night shift (5:45 pm – 6:15 am).
Requirements
- Bachelor of Science degree in Biology, Chemistry, Biotechnology, or a related field, or equivalent relevant experience
- Hands-on experience in a regulated manufacturing or cGMP environment
- Strong understanding of aseptic manufacturing principles
- Ability to troubleshoot equipment and process issues and support deviation investigations
- Ability to accurately complete manufacturing documentation following procedures and quality standards
- Effective written and verbal communication skills
- Near vision equivalent to 20/20 with no color vision impairment; corrective lenses permitted
Benefits
- Health Insurance
- Life Insurance
- Disability Benefits
- 401(k) Matching
- Paid Time Off
- Vacation
- Personal Days
- Holidays
- Performance-Based Cash Incentive
- Annual Equity Awards
Company overview
Novartis is a global pharmaceutical company headquartered in Basel, Switzerland, dedicated to reimagining medicine to improve and extend people's lives. As an innovative medicines company, Novartis focuses on developing high-value treatments that address society's greatest disease burdens through technology leadership in research and development. The company operates across five core therapeutic areas: cardiovascular, renal and metabolic diseases; immunology; neuroscience; oncology; and hematology. With a workforce of approximately 75,883 employees worldwide, Novartis reaches nearly 300 million patients across 118 countries. The company leverages advanced technology platforms including targeted protein degradation, cell therapy, gene therapy, radioligand therapy, and xRNA to develop breakthrough treatments. Novartis maintains a strong portfolio of oncology drugs and generics while continuously expanding its pipeline through strategic acquisitions and internal research. The company's commitment extends beyond drug development to ensuring global access to medical innovations through novel access approaches and patient assistance programs.