BioProcess Engineer I / II

U473 (FCRS = US473) Novartis Innovative Technologies Inc; North Carolina; On-site; USD 67,000 - 124,000; Full time

Job summary

Novartis in Durham, NC seeks a Bioprocess Engineer I/II to perform hands-on drug product manufacturing, including fill-finish, inspection, and packaging. You will work with Operations and Quality to ensure safe, compliant production and document real-time manufacturing steps.

The role requires a BS in a related field or equivalent experience, with GMP experience and strong aseptic discipline. Night shift rotations and onsite work in Durham are expected.

Qualifications

• Hands-on experience in regulated manufacturing environments.
• Strong aseptic manufacturing principles and disciplined execution.
• Ability to troubleshoot equipment and process issues.
• Proven completion of manufacturing documentation following procedures.
• Effective written and verbal communication across teams.
• Near vision 20/20 with or without corrective lenses.

Responsibilities

• Execute hands-on drug product manufacturing across fill-finish, inspection, packaging, and media prep.
• Operate, monitor, and adjust equipment to ensure safe, efficient production.
• Troubleshoot equipment and process issues, escalating as needed.
• Maintain aseptic techniques in controlled manufacturing environments.
• Support deviations and contribute to root cause analysis and corrective actions.
• Complete batch records and manufacturing documentation in real time.

Skills

Good Manufacturing Practices

General Hse Knowledge

Education

BS in Biology, Chemistry, Biotechnology, or related field

2 years' experience in cGMP or equivalent

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. If you're motivated by precision, ownership, and seeing the direct results of your work in a regulated manufacturing environment, this role offers the opportunity to build mastery while supporting products patients depend on.

Job Description Location: 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.

Shift: This role will work on a rotating 2-2-3 night shift (5:45 pm - 6:15 am).

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

• 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 2 years' 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.

Novartis Compensation and Benefit Summary

The salary for this position is expected to range between: Bioprocess Engineer I, $22.84 and $42.46; Bioprocess Engineer II/III, $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, eligibility to be considered for annual equity awards. US 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. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

Salary Range

$66,800.00 - $124,000.00

Skills Desired

• General Hse Knowledge (Inactive)


• Good Manufacturing Practices (GMP)

Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives.

EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility and Reasonable Accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process or to perform the essential functions of a position, please send an e-mail to [e-mail] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.