BioProcess Engineer I/II/III (Downstream)

Job Description Summary

#LI-Onsite
This position will be located at 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.
A Bioprocess Engineer Downstream/Fill-Finish plays a critical role in the manufacturing operations at a plant or site. This position is pivotal in ensuring the smooth execution of production processes, organizing and running operations effectively, and continuously improving the manufacturing workflow.

Job Description

Role Responsibilities:

• Performs commercial and clinical manufacturing operations on-site, including purification (downstream), fill-finish (drug product, visual inspection, packaging), media/buffer preparation, and any additional supporting activities.
• Troubleshoot equipment, collaborate with other business units to aid in manufacturing-led deviations, standardize equipment, and clean production areas.
• Assists in identifying root causes, implementing solutions, and verifying the effectiveness of those solutions.
• Contributes to the creation and ongoing maintenance of all pertinent equipment policies and procedures.
• Acquires and applies aseptic techniques relevant to cell culture, recovery, purification, aseptic fill/finish (upstream and downstream).
• Supports product requirements to ensure that all products are manufactured according to plan. Learns cGMP and cGDP protocols, ensures accurate completion of cGMP documentation, maintains current training, and adheres to all quality standards.
• Maintains quality standards to meet cGMP requirements, CFRs, and internal company policies directly related to the manufacturing process.
• Collaborates with the Quality department to ensure a compliant manufacturing environment

Shift: This role is Mon-Fri, AM Shift. 7:00am-3:30pm

Role Requirements:

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

• For Bioprocess Engineer I – Bachelor of Science Degree in Biology, Chemistry, Biotechnology or applicable field or 2 years equivalent 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
• Excellent oral and written communication skills
• 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.

Novartis Compensation and Benefit Summary:

The salary for this position is expected to range between: for Bioprocess Engineer I, $22.84 and $42.46; for 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.

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

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.