BioProcess Engineer II_III - DP (PM Shift) at Novartis

Durham, California, United States -

Full Time

Start Date

Immediate

Expiry Date

30 May, 26

Salary

124000.0

Posted On

01 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Fill-Finish Operations, Visual Inspection, Packaging, Media And Buffer Preparation, Aseptic Discipline, cGMP, Equipment Troubleshooting, Deviation Support, Root Cause Analysis, Continuous Improvement, Quality Assurance, Batch Record Completion, Aseptic Techniques, Isolators, Process Monitoring

Industry

Pharmaceutical Manufacturing

Description

Job Description Summary #LI-Onsite This position will be located on-site in Durham, NC and will not have the ability to be located remotely. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. *** The BioProcess Engineer is a Manufacturing role.*** Join a (DP) Drug Product–focused manufacturing team where attention to detail, aseptic discipline, and patient impact are central to the work you do. As a BioProcess Engineer, you’ll support fill‑finish operations, visual inspection, packaging, and media and buffer preparation, helping ensure drug product is manufactured safely, consistently, and in full alignment with current Good Manufacturing Practice requirements. You’ll apply hands‑on experience from regulated manufacturing environments to troubleshoot equipment, support manufacturing‑led deviations, and contribute to effective root cause analysis and continuous improvement. Partnering closely with Quality and Operations, you’ll help maintain a compliant, inspection‑ready operation while strengthening robust drug product processes that patients can trust. Job Description Key Responsibilities: Execute commercial and clinical drug product manufacturing, including fill‑finish, visual inspection, packaging, and buffer preparation. Operate and monitor manufacturing equipment to ensure safe, efficient, and compliant drug product production. Troubleshoot equipment and process issues, escalating and collaborating cross‑functionally to minimize production impact. Support manufacturing‑led deviations, contributing to root cause analysis and effective corrective and preventive actions. Apply and maintain strong aseptic techniques during all drug product manufacturing activities. Ensure strict adherence to current Good Manufacturing Practice standards, standard operating procedures, and documentation requirements. Accurately complete batch records and manufacturing documentation to support inspection‑ready operations. Maintain clean and organized production areas in alignment with safety and quality standards. Partner closely with Quality to sustain a compliant manufacturing environment and support audits or inspections. Contribute to continuous improvement initiatives that strengthen drug product processes, reliability, and efficiency. Shift: The shift for this role operates on a 2-2-3 PM Shift schedule. Approximate start/end times are 5:45pm - 6:15am. Role Requirements: **The level of the role will be determined by the years of relevant experience. For Bioprocess Engineer II - Bachelor of Science Degree in Biology, Chemistry, Biotechnology or applicable field and 2 years’ experience in cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish environment; OR four (4) years’ experience in cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish environment in lieu of degree; For Bioprocess Engineer III - Bachelor of Science Degree in Biology, Chemistry, Biotechnology or applicable field and 4 years’ experience in cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish environment; OR six (6) years’ experience in cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish environment in lieu of degree Hands‑on experience supporting drug product manufacturing, including fill‑finish operations, inspection, or packaging activities. Strong understanding of aseptic manufacturing principles and disciplined execution in controlled production environments. Demonstrated ability to troubleshoot equipment and process issues and support manufacturing‑led deviation investigations. Experience completing accurate manufacturing documentation and maintaining compliance with standard operating procedures and quality standards. Effective written and verbal communication skills, with the ability to collaborate across Operations, Quality, and technical teams. Near vision performance should be the equivalent of 20/20 with no impairment of color vision. The use of corrective lenses to achieve the desired visual acuity is permitted. Desirable Requirements: Familiarity with isolators and advanced aseptic processing concepts used in modern drug product manufacturing. Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $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. To learn more about the culture, rewards and benefits we offer our people click here. Company will not sponsor visas for this position. 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 us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $66,800.00 - $124,000.00 Skills Desired General Hse Knowledge , gmp knowledge 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. Novartis is aware of employment scams which make false use of our company name or leader’s names or recruiter’s names to defraud job seekers. Novartis does not make job offers without interview and never asks candidates for money. If you have encountered a job posting or been approached with a job offer that you suspect may be fraudulent, we strongly recommend you do not respond, send money or personal information. In the context of China Cross-Border Data Transfer (CBDT) policy, if you need to apply for a position in China, please go to the local Recruiting System TaleNov .

Responsibilities

The BioProcess Engineer will execute commercial and clinical drug product manufacturing, focusing on fill-finish, visual inspection, packaging, and buffer preparation while operating and monitoring manufacturing equipment. Key duties include troubleshooting issues, supporting manufacturing-led deviations, and ensuring strict adherence to cGMP standards and documentation requirements.