Senior Process Engineer - Manufacturing Sciences & Technology

Catalent Pharma Solutions; United States; On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Paid holidays & PTO

Medical/dental/vision benefits

Tuition reimbursement

Equal opportunity employer

Job summary

Catalent's Madison, Wisconsin site seeks a Senior Process Engineer - Manufacturing Sciences & Technology, Downstream, to drive downstream biologics processes and technology transfer into GMP manufacturing. You’ll collaborate across Process Development, Manufacturing, QA/QC, and Facilities to enable robust, scalable operations and ensure regulatory readiness.

The role emphasizes developing and guiding process transfer strategies, authoring technical documents, supervising staff, and leading

Qualifications

• Minimum of Associate’s degree in STEM with 12+ years of related experience, or Bachelor’s in STEM with 6+ years, or Master’s with 4+ years, or Doctorate in STEM without formal industry 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.
• Proven leadership experience managing and mentoring staff, including cross‑functional training and personnel development.
• Hands‑on experience investigating, resolving, and closing deviations, out‑of‑specification events, change controls, and CAPAs in a cGMP‑regulated environment.
• Technical expertise in downstream biologics manufacturing processes such as depth filtration, chromatography, tangential flow filtration, and viral filtration, including facility fit, process scaling, and technology transfer.
• Operational engineering experience supporting late‑phase, PPQ, and commercial programs, including design, qualification, operation, and troubleshooting of single‑use systems and manufacturing equipment for biologics and molecular therapeutics.

Responsibilities

• Oversee technical support of Manufacturing, including technology transfer between external clients or Process Development and Manufacturing.
• Collaborate with engineers, scientists, and colleagues to drive facility fit and technical transfer of mammalian biologic processes.
• Evaluate, align, and recommend equipment and process improvements.
• Support technology transfer of processes into manufacturing for internal and external projects.
• Develop and execute technical work plans and schedules independently using customer milestones and site performance standards.
• Author and approve technical documents such as protocols, technology transfer reports, operating procedures, and batch production records.
• Review technical documents for accuracy, thoroughness, and regulatory compliance.
• Train, coach, and mentor others on technical topics.
• Participate in client meetings, providing technical support and leading projects as a technical lead across multiple disciplines.
• Identify and recommend business opportunities on a project-specific basis.
• Work cross-functionally with Process Development, Manufacturing, QA, QC, Supply Chain, Project Management, and Facilities to ensure effective process transfer and maintenance.
• Support strategic alignment across Catalent Biologics sites, including the Madison site.
• Collaborate with Manufacturing to author batch documentation and provide technical and strategic oversight for GMP manufacturing.
• Compile process data, communicate project status, identify trends, and deliver internal or client presentations.
• Evaluate existing processes and identify process or equipment improvements to enhance efficiency and competitiveness.
• Support the development of business cases for process improvement projects.
• Author and review documents including batch production records, tech transfer reports, bill of materials, process descriptions, project reports, engineering specifications, and summary reports.
• Lead or support risk assessments, gap analyses, deviations, change controls, and CAPAs, including root-cause analysis and corrective action identification.
• Other duties as assigned.

Skills

Technology transfer

Process engineering

Downstream bioprocessing

Team leadership

cGMP compliance

Education

Associate degree in STEM

Bachelor’s degree in STEM

Master’s degree in STEM

PhD in STEM

Tools

Single-use systems

Chromatography

Tangential flow filtration

Viral filtration

Job description

About Site

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 Senior Process Engineer - Manufacturing Sciences & Technology, Downstream to join our team. This role supports the MS&T department, which provides technical services for process and technology transfer between Process Development and GMP manufacturing. The position focuses on downstream biologics processes, ensuring successful technology transfer, process readiness, and execution support. The engineer will collaborate across departments to enable robust, compliant, and scalable manufacturing operations.

The Role

Shift: Monday-Friday 8am-5pm (compensated on-call rotation)

Location: Madison, WI 100% Onsite

• Oversee technical support of Manufacturing, including technology transfer between external clients or Process Development and Manufacturing.
• Collaborate with engineers, scientists, and colleagues to drive facility fit and technical transfer of mammalian biologic processes.
• Evaluate, align, and recommend equipment and process improvements.
• Support technology transfer of processes into manufacturing for both internal and external projects.
• Develop and execute technical work plans and schedules independently using customer milestones and site performance standards.
• Author and approve technical documents such as protocols, technology transfer reports, operating procedures, and batch production records.
• Review technical documents for accuracy, thoroughness, and regulatory compliance.
• Train, coach, and mentor others on technical, development, or business topics.
• Participate in client meetings, providing technical support and leading projects as a technical lead across multiple disciplines.
• Identify and recommend business opportunities on a project-specific basis.
• Work cross-functionally with Process Development, Manufacturing, Quality Assurance, Quality Control, Supply Chain, Project Management, and Facilities to ensure effective process transfer and maintenance.
• Support strategic alignment across Catalent Biologics sites, including the Madison site.
• Collaborate with Manufacturing to author batch documentation and provide technical and strategic oversight for GMP manufacturing.
• Compile process data, communicate project status, identify trends, and deliver internal or client presentations.
• Evaluate existing processes and identify process or equipment improvements to enhance efficiency and competitiveness.
• Support the development of business cases for process improvement projects.
• Author and review documents including batch production records, tech transfer reports, bill of materials, process descriptions, project reports, engineering specifications, and summary reports.
• Lead or support risk assessments, gap analyses, deviations, change controls, and CAPAs, including root-cause analysis and corrective action identification.
• Other duties as assigned.

The Candidate Minimum Requirements

• Minimum of Associate’s degree in STEM with 12+ years of related experience, or Bachelor’s in STEM with 6+ years, or Master’s with 4+ years, or Doctorate in STEM without formal industry 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.
• Proven leadership experience managing and mentoring staff, including cross‑functional training and personnel development.
• Hands‑on experience investigating, resolving, and closing deviations, out‑of‑specification events, change controls, and CAPAs in a cGMP‑regulated environment.
• Technical expertise in downstream biologics manufacturing processes such as depth filtration, chromatography, tangential flow filtration, and viral filtration, including facility fit, process scaling, and technology transfer.
• Operational engineering experience supporting late‑phase, PPQ, and commercial programs, including design, qualification, operation, and troubleshooting of single‑use systems and manufacturing equipment for biologics and molecular therapeutics.

Preferred Skills & Background

Subject Matter Expert on large‑scale or commercial‑scale biologics and mRNA manufacturing, including depth filtration, chromatography, tangential flow filtration, and viral filtration in a GMP‑regulated environment.

Physical requirements

• Must be able 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 EHS responsibilities.

Why You Should Join Catalent

• 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 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 [e-mail]. 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.

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Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life‑cycle supply. With time‑tested experience in development sciences, delivery technologies, and multi‑modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life‑enhancing and life‑saving treatments for patients annually.