Bioprocess Engineer II / III

Job Description Summary

#LI-Onsite
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 on-site 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 site’s 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, CFR’s, 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 hands-on 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 2-2-3 rotating shift schedule. 6am-6pm

Role Requirements:

• Bachelor's of Science Degree in Biology, Chemistry, Biotechnology or applicable field with minimum 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

• Minimum 3-5 years’ experience in cGMP 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.

______

• 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 sign-on 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 “at-will 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 e-mail to [email protected] 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

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