Bioprocess Engineer II / III

Job Description Summary

#LIOnsite

The Bioprocess Engineer II / III is responsible for organizing running sustaining and continuously improving the manufacturing operations process at the plant/site. Perform manufacturing tasks according to schedule ensuring products meet quality standards and comply with GMP safety and environmental regulations.

*The role level will be determined by years of relevant experience.

The role is located onsite in our Durham NC location. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

Job Description

Role Responsibilities:

• Produces clinical and commercial material on an annual basis that meets the sites strategic objectives and is compliant with cGMPs.
• Works on the manufacturing floor to produce product troubleshoot equipment and provide ownership for specific pieces of processing equipment.
• Ensures cGMP documentation is being filled out correctly training is current and all Quality requirements are being followed.
• Participates in tours or information requests for all external and internal audits of the manufacturing facilities/processes.
• Maintains quality standards to meet cGMP requirements CFRs and internal company policies related to the manufacturing process.
• Supports tech transfer of new products and processes to ensure smooth transition from process development into GMP manufacturing.
• Provides handson technical leadership to the manufacturing staff members.
• Looks for opportunities to implement operational excellence and continuous improvement.
• Partners with Quality to ensure a quality and compliant manufacturing environment.
• Supports leadership to meet information requirements for quality compliance and management reporting.

Shift: This role is a 223 rotating shift schedule. 6am6pm

Role Requirements:

• Bachelors of Science Degree in Biology Chemistry Biotechnology or minimum 35 years experience in cGMP within 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.
• Excellent oral and written communication skills. Strong technical writing ability.
• Ability to motivate peers and staff foster a culture of continuous improvement and operation excellence.
• Experience with 3rd parties (equipment vendors and contract manufacturing insourcing/outsourcing).
• Ability to routinely lift over 35 lbs.

The pay range for this position at commencement of employment is expected to be between $32.12 to $59.62/hr; however while salary ranges are effective from 1/1/25 through 12/31/25 fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further final pay determinations will depend on various factors including but not limited to geographical location experience level knowledge skills and abilities. The total compensation package for this position may also include other elements including a signon bonus restricted stock units and discretionary awards in addition to a full range of medical financial and/or other benefits (including 401(k) eligibility and various paid time off benefits such as vacation sick time and parental leave) dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired employee will be in an atwill position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.

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 email to or call 1(877)and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$66800.00 $124000.00

Skills Desired

Assembly Language Cooperation Efficiency Electronic Components Flexibility General Hse Knowledge Good Documentation Practice Installations (Computer Programs) Iso (International Organization For Standardization) Job Description Knowledge Of Gmp Lean Manufacturing Manufacturing Process Manufacturing Production Nuclear Medicine Physics Product Distribution Production Line Scheduler