Process Engineer - Manufacturing Sciences & Technology
Catalent Pharma Solutions, Madison, WI, United States
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).
About the Facility
Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO). The Madison, WI facility features advanced mammalian cell line engineering and biomanufacturing capabilities using single‑use systems to support scalable production within a 263,000 sq. ft. GMP environment.
Role
Provide technical support to Manufacturing; lead facility fit, equipment alignment, and technology transfer of biologic processes.
Execute technical work plans and schedules, including data generation and entry; perform engineering and process calculations.
Draft, author, and review technical documentation (development reports, technical transfer reports, batch production records, engineering specifications, 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 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 improvement opportunities to enhance efficiency, consistency, and competitiveness.
Compile, analyze, and communicate process and project data, including status reporting, trend analysis, and presentations.
Partner cross‑functionally with Process Development, Manufacturing, Quality Assurance, Quality Control, Supply Chain, Project Management, Facilities, and other stakeholders.
Participate in client meetings, providing technical expertise and program support.
Train, mentor, and coach junior staff on laboratory, manufacturing, and engineering principles; serve as subject‑matter expert.
Other duties as assigned.
Candidate
Minimum 6 years related experience and an Associate’s degree in STEM. Preference for Bachelor’s/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.
Demonstrated experience authoring, revising, and reviewing technical documentation supported by statistical data analysis and reporting.
Proven leadership experience managing and mentoring staff.
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 (filtration, chromatography, TFF, viral filtration).
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: must be able to see, hear, read, and write clear English; frequent sitting, standing, walking, reading of written documents, computer use, reaching with hands and arms; occasional stooping, kneeling, crouching, bending, carrying, grasping; can lift up to 10 pounds frequently and up to 50 pounds occasionally.
Benefits
Defined career path and annual performance review and feedback process.
Diverse, inclusive culture.
Growth potential on an expanding team.
152 hours of PTO + 8 paid holidays.
Generous 401(k) match.
Medical, dental, and vision benefits.
Tuition reimbursement.
Equal Opportunity
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, please contact DisabilityAccommodations@catalent.com with the job number, title, and location.
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Position Summary:
Work Schedule: Monday – Friday, core hours 8am-5pm. 100% on-site (Madison, WI).
About the Facility
Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO). The Madison, WI facility features advanced mammalian cell line engineering and biomanufacturing capabilities using single‑use systems to support scalable production within a 263,000 sq. ft. GMP environment.
Role
Provide technical support to Manufacturing; lead facility fit, equipment alignment, and technology transfer of biologic processes.
Execute technical work plans and schedules, including data generation and entry; perform engineering and process calculations.
Draft, author, and review technical documentation (development reports, technical transfer reports, batch production records, engineering specifications, 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 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 improvement opportunities to enhance efficiency, consistency, and competitiveness.
Compile, analyze, and communicate process and project data, including status reporting, trend analysis, and presentations.
Partner cross‑functionally with Process Development, Manufacturing, Quality Assurance, Quality Control, Supply Chain, Project Management, Facilities, and other stakeholders.
Participate in client meetings, providing technical expertise and program support.
Train, mentor, and coach junior staff on laboratory, manufacturing, and engineering principles; serve as subject‑matter expert.
Other duties as assigned.
Candidate
Minimum 6 years related experience and an Associate’s degree in STEM. Preference for Bachelor’s/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.
Demonstrated experience authoring, revising, and reviewing technical documentation supported by statistical data analysis and reporting.
Proven leadership experience managing and mentoring staff.
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 (filtration, chromatography, TFF, viral filtration).
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: must be able to see, hear, read, and write clear English; frequent sitting, standing, walking, reading of written documents, computer use, reaching with hands and arms; occasional stooping, kneeling, crouching, bending, carrying, grasping; can lift up to 10 pounds frequently and up to 50 pounds occasionally.
Benefits
Defined career path and annual performance review and feedback process.
Diverse, inclusive culture.
Growth potential on an expanding team.
152 hours of PTO + 8 paid holidays.
Generous 401(k) match.
Medical, dental, and vision benefits.
Tuition reimbursement.
Equal Opportunity
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, please contact DisabilityAccommodations@catalent.com with the job number, title, and location.
#J-18808-Ljbffr