Senior Process Engineer - Manufacturing Sciences & Technology

Catalent Pharma Solutions; Madison (WI); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

Tuition reimbursement

Paid time off & holidays

Job summary

Catalent is seeking a Senior Process Engineer in Manufacturing Sciences & Technology, Downstream, at its Madison, WI site. The role ensures successful technology transfer, process readiness, and execution support for downstream biologics projects.

You will collaborate across Process Development, Manufacturing, Quality, and Facilities to enable robust, compliant operations and drive improvements across teams, with a focus on scalable biomanufacturing.

Qualifications

• Degree in STEM with 12+ years (Assoc.), 6+ years (Bachelor’s), 4+ years (Master’s) or Doctorate without formal industry experience.
• Experience in mRNA product development, mRNA manufacturing, protein therapeutics, and late-stage/commercial manufacturing.
• Proven ability to author/revise technical docs and reports with data support.
• Leadership experience mentoring staff and cross‑functional training.
• Hands‑on experience resolving deviations, CAPAs, and change controls in cGMP.

Responsibilities

• Oversee technical support for manufacturing, including tech transfer between Process Development and Manufacturing.
• Collaborate across disciplines to drive equipment fit and process transfer for biologics.
• Evaluate and implement equipment and process improvements.
• Lead or support risk assessments, deviations, and CAPAs.
• Prepare batch records, tech transfer reports, SOPs, and documentation.
• Train and mentor staff; present project status to clients or internal teams.
• Work cross‑functionally to ensure compliant, scalable manufacturing.

Education

Associate’s degree in STEM

Bachelor’s in STEM

Master’s in STEM

Doctorate in STEM

Tools

Single‑use systems

cGMP environment

Tech transfer

Job description

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.

Shift: Monday-Friday 8am-5pm (compensated on-call rotation)
Location: Madison, WI
100% Onsite

The Role

• 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.
• 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.

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.

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.

Catalent is an Equal Opportunity Employer, including disability and veterans.

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.