Bioprocess Engineer Downstream (PM Shift)

Job Description Summary

Job Description

Key Responsibilities:

• Execute commercial and clinical drug product manufacturing, including fillfinish, 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 crossfunctionally to minimize production impact.
• Support manufacturingled 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 inspectionready 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
• Handson experience supporting drug product manufacturing, including fillfinish 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 manufacturingled 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

Skills Desired