Process Engineer - Manufacturing Sciences & Technology, Upstream

About Site Catalent’s Madison, Wisconsin site is a state‑of‑the‑art biologics development and manufacturing facility supporting customers from research through early‑ and mid‑stage clinical production. Located at 726 Heartland Trail in Madison, the approximately 102,700‑square‑foot GMP facility specializes in mammalian cell line engineering, drug substance biomanufacturing, and biopharmaceutical development, utilizing flexible single‑use systems to enable rapid scale‑up and customization. The site is home to Catalent’s proprietary GPEx® and GPEx® Lightning technologies, which are used to generate high‑yielding mammalian cell lines for biologic therapies, and supports production scales ranging from 50 to 4,000 liters for clinical manufacturing. Following a $45 million expansion announced in 2025, the Madison site has significantly increased capacity, added new equipment, and created approximately 200 highly skilled biohealth jobs, further strengthening its role within Catalent’s global biologics network and Wisconsin’s growing life sciences ecosystem. Position Summary We have an opportunity for a Process Engineer - Manufacturing Sciences & Technology, Upstream Technology Transfer to join our team. This role supports technology transfer and process readiness for biologics manufacturing. You will work closely with cross-functional teams to ensure successful transfer and execution of upstream processes. The position offers the chance to contribute to innovative projects in a dynamic, GMP-regulated environment. Shift: Monday-Friday, 8am-5pm (compensated on-call rotation) Location: Madison, WI 100% Onsite The Role • Provide technical support to Manufacturing, leading facility fit, equipment alignment, and technology transfer of biologic processes from Process Development and external clients. • Evaluate and recommend process and equipment improvements while supporting technology transfer for both internally and externally developed manufacturing processes. • Execute technical work plans and schedules, including data generation and entry, in collaboration with supervisors or senior team members. • Perform engineering and process calculations to support development, tech transfer, and GMP manufacturing programs. • Draft, author, and review technical documentation, including development reports, technical transfer reports, batch production records, engineering specifications, and summary reports. • Conduct technical reviews of laboratory and engineering documentation to ensure accuracy, completeness, and regulatory compliance. • Support GMP manufacturing through technical oversight, batch documentation authoring, and close collaboration with Manufacturing teams. • Lead or support risk assessments, gap analyses, deviations, change controls, and CAPAs, including root cause analysis and impact assessment. • Evaluate existing processes and identify process or equipment improvement opportunities to enhance efficiency, consistency, and operational competitiveness. • Compile, analyze, and communicate process and project data, including status reporting, trend analysis, and internal or client-facing presentations. • Partner cross-functionally with Process Development, Manufacturing, Quality Assurance, Quality Control, Supply Chain, Project Management, Facilities, and other stakeholders to enable effective process transfer and sustainment. • Support strategic alignment and knowledge sharing across sites, including coordination with Madison and other Catalent Biologics locations. • Participate in client meetings, providing technical expertise and program support. • Train, mentor, and coach junior staff on laboratory, manufacturing, and engineering principles; serve as a subject matter expert. • Other duties as assigned. The Candidate Minimum Requirements • Minimum of Associate’s degree in STEM with 6+ years of related experience, or Bachelor’s and/or Master’s with at least 3+ years of related experience. • Experience in mRNA product development, mRNA manufacturing, protein therapeutics manufacturing, and late stage/commercial manufacturing. • Experience authoring, revising, and reviewing technical documentation, including reports, standard operating procedures, and batch production records, supported by statistical data analysis and reporting. • Proven leadership experience managing and mentoring staff, including cross-functional training, personnel development, and organizational team support. • Hands-on experience investigating, resolving, and closing deviations, out-of-specification events, change controls, and CAPAs in a cGMP-regulated environment. • Technical subject matter expertise in upstream (e.g., mammalian cell culture, in vitro transcription) and/or downstream biologics manufacturing processes (e.g., filtration, chromatography, tangential flow filtration, viral filtration), including facility fit, process scaling, and technology transfer across cGMP production scales. • Operational engineering experience supporting late-phase, process performance qualification, and commercial programs, including design, onboarding, qualification, operation, and troubleshooting of single-use systems, consumables, and manufacturing equipment for biologics and molecular therapeutics. • Physical requirements: Ability to see, hear, read, and write clear English. Frequent sitting, standing, walking, reading, and computer use. Occasional stooping, kneeling, crouching, bending, carrying, and grasping. Frequent lifting up to 10 pounds and occasional lifting up to 50 pounds. Must comply with Environmental Health and Safety responsibilities. Preferred Skills & Background • Subject matter expertise on large scale/commercial scale biologics and mRNA manufacturing (including mammalian cell culture and/or in vitro transcription) in GMP-regulated environment. Why You Should Join Catalent • Defined career path and annual performance review and feedback process • Diverse, inclusive culture • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives • Competitive paid time off plus 8 paid holidays • Community engagement and green initiatives • Medical, dental, and vision benefits effective day one of employment • Tuition reimbursement Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE . Volunteer Work Disclosure: Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis. Massachusetts Lie Detector Test Notice: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.