Bioprocess Engineer I / Ii

Novartis; North Carolina; On-site; USD 30,000 - 83,000; Full time

Job summary

Novartis in Durham, NC is seeking Bioprocess Engineer I/II to contribute to hands-on drug product manufacturing, including fill-finish, inspection, and packaging, with strong aseptic discipline. You will operate equipment, troubleshoot real-time issues, and maintain compliant documentation while collaborating with Quality and Operations to keep production safe and ready for audits.

This role requires a BS in a relevant field; II level requires 2 years of cGMP experience and the ability to work a

Qualifications

• BS in Biology, Chemistry, Biotechnology or related field or equivalent experience.
• For II: BS degree and 2 years in cGMP or equivalent experience.
• Hands-on experience in a regulated manufacturing environment.
• Strong aseptic manufacturing principles and disciplined execution.
• Ability to troubleshoot equipment/process issues and support deviations.
• Accurate manufacturing documentation following procedures and quality standards.
• Effective written and verbal communication across Operations, Quality and technical teams.
• Near vision 20/20 with no color vision impairment (corrective lenses allowed).

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 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.

Skills

Aseptic manufacturing

cGMP

Troubleshooting

Documentation

Quality collaboration

Communication

Education

Bachelor of Science in Biology, Chemistry, Biotechnology or related field

2 years' experience in cGMP or applicable field

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.

About the Role

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.

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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 & 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 [email protected] 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.