Process Engineer Manufacturing Sciences & Technology

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)

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 263000 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 atscale 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 billofmaterials 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 handson 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 Associates degree in STEM with 6 years of related experience. It is preferred to have a Bachelors and/or Masters 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 crossfunctional training personnel development and organizational team support.
• Handson 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 latephase PPQ and commercial programs including design onboarding qualification operation and troubleshooting of singleuse 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 7000 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 . 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.

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