Bioprocess Engineer III/IV, Days (Upstream)

Job Description Summary

The Bioprocess Engineer III/IV for Cell Expansion/Upstream is responsible for assisting with organizing running and sustaining the manufacturing operations process at the site. Perform manufacturing tasks according to schedule ensuring products meet quality standards and comply with cGMP 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

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.
• Mentors and provides hands-on training to newly hired Bioprocess Engineers.
• Ensures cGMP documentation is being filled out correctly training is current and all Quality requirements are being followed.
• Participates in information requests for all FDA 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.
• Leads tech transfer of new products and processes to ensure smooth transition from process development into GMP manufacturing.
• 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:

Bioprocess Engineer III:

• Bachelors of Science Degree in Biology Chemistry Biotechnology or applicable field with minimum 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

• A minimum 6 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.

Or

• Bachelors degree in Biology Chemistry Biotechnology or applicable field with 3 years experience in the manufacturing of Novartis Gene Therapies product;

Bioprocess Engineer IV:

• Bachelors of Science Degree in Biology Chemistry Biotechnology or applicable field with 5 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

• A minimum 7 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;

Or

• Bachelors degree in Biology Chemistry Biotechnology or applicable field with 3 years experience in the manufacturing of Novartis Gene Therapies product.

Requirements for both levels:

• 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.
• Ability to routinely lift over 35 lbs.

The salary for this position is expected to range between: for Bioprocess Engineer III: $32.12 and $59.62 per hour; for Bioprocess Engineer IV: $37.02 and $68.75 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 -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 addition employees are eligible for a generous time off package including vacation personal days holidays and other leaves.

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 or call 1 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