Process Engineer - Manufacturing Sciences & Technology (MS&T), Downstream Technology Transfer

Catalent Pharma Solutions; Alabama; On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

152 hours PTO + 8 holidays

401K match

Medical, dental and vision benefits

Tuition Reimbursement

Job summary

Catalent Pharma Solutions in Madison, WI, is seeking a Process Engineer for MS&T downstream tech transfer to enable transfer of biologic processes from development to GMP manufacturing. The role requires deep experience in mammalian cell culture, process transfer, and technical documentation, with leadership responsibilities and cross‑functional collaboration.

You will support facility fit, equipment alignment, data-driven improvements, and risk assessments across cGMP programs, including

Qualifications

• Must have an Associate’s degree in STEM with 6+ years of related experience.
• Bachelor’s and/or Master’s with at least 3+ years of related experience preferred.
• Experience in mRNA product development/manufacturing and protein therapeutics MFG.
• Experience authoring, revising, and reviewing technical documentation with statistical data analysis.

Responsibilities

• Provide technical support for facility fit, equipment alignment, and technology transfer of biologic processes.
• Evaluate process and equipment improvements while supporting tech transfer.
• Execute technical work plans, data generation, and entry in collaboration with supervisors.
• Perform engineering and process calculations to support development, tech transfer, and GMP manufacturing.
• Draft and review development reports, tech transfer reports, batch records, and specs.
• Lead or support risk assessments, deviations, CAPAs, with root cause analysis.

Skills

Mammalian cell culture

Upstream/downstream tech transfer

Technical documentation

CAPA and deviation handling

Leadership/mentoring

Process calculations

cGMP manufacturing

Project management

Statistical data analysis

Education

Associate’s degree in STEM

Bachelor’s or Master’s degree (preferred)

Tools

Single-use systems

GMP equipment

Job description

Process Engineer - Manufacturing Sciences & Technology (MS&T), Downstream Technology Transfer

Position Summary

Work Schedule: Monday – Friday, core hours 8am-5pm 100% on-site (Madison, WI) On-call rotation (Compensated) Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO). Located in Madison, WI, this facility features advanced mammalian cell line engineering and biomanufacturing capabilities using single-use systems to support scalable production. This 263,000 sq. ft. Good Manufacturing Practice (GMP) facility offers integrated formulation and analytical services to address complex development challenges in Biologics.

The Process Engineer for MS&T supports the department which serves as an agile technical services organization supporting process and technology transfer between Process Development (internal and external) and at‑scale GMP manufacturing. The Technology Transfer groups (Upstream and Downstream) act as the primary technical liaisons, ensuring successful transfer and execution of biologic processes across a range of modalities, including monoclonal antibodies, fusion proteins, enzymes, mRNA, and emerging technologies.

Department responsibilities include process modeling, facility fit assessments, initial bill‑of‑materials development, and evaluation of equipment and consumables, as well as authoring and supporting critical manufacturing documentation such as gap assessments, technical reports, product impact assessments, and batch records. MS&T also provides hands‑on process readiness and execution support to enable robust, compliant, and scalable manufacturing operations.

The Role

Downstream Tech Transfer Duties

• 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 parallel 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

• Must have a minimum of Associate’s degree in STEM with 6+ years of related experience.
• It is preferred to have a Bachelor’s and/or Master’s with at least 3+ years of related experience.
• Related experience encompasses mRNA product development experience, mRNA manufacturing, protein therapeutics MFG, and late stage/commercial MFG.
• Demonstrated experience authoring, revising, and reviewing technical documentation, including reports, standard operating procedures (SOPs), 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, OOS events, change controls, and CAPAs in a cGMP‑regulated environment.
• Technical subject matter expertise in upstream (e.g., mammalian cell culture, IVT) and/or downstream biologics manufacturing processes (e.g., filtration, chromatography, TFF, viral filtration), including facility fit, process scaling, and technology transfer across cGMP production scales.
• Operational engineering experience supporting late‑phase, PPQ, 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: Individual must be able to see, hear, read, and write clear English. Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds. Must comply with EHS responsibilities.

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
• 152 hours of PTO + 8 paid holidays
• Generous 401K match
• Medical, dental and vision benefits
• Tuition Reimbursement - Let us help you finish your degree or start a new degree!

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 [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.

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.

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.

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.