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 an Engineer I - Engineering, Validation to join our team in Madison, WI. This role supports quality assurance and validation activities to ensure compliance with regulatory and internal quality standards. The position involves oversight of validation programs, commissioning and qualification of equipment, and collaboration with cross‑functional teams to maintain high standards of quality and compliance. The successful candidate will contribute to continuous improvement and support the manufacture and release of high‑quality drug substances.
Shift: M-F 8am-5pm
Location: Madison, WI
100% Onsite
The Role
Review and approve validation documents
Support commissioning and qualification of equipment and utilities
Lead validation activities for new equipment and systems
Serve as QA subject matter expert for Validation and Risk Management
Assess change controls for impact to validated systems
Support audits and regulatory inspections
Investigate deviations related to validation activities
Maintain Validation Master Plan
Partner with Manufacturing, Process Development, Facilities, Regulatory Affairs, and Quality teams
Manage validation contractors when necessary
Provide training and technical support
The Candidate
Minimum Requirements
Bachelor's degree in a technical field (Biology, Biotechnology, Engineering, or related) with 7+ years of relevant experience OR Master's degree in a technical field with 4+ years of relevant experience
Strong knowledge of cGMP regulations
Knowledge of validation standards including ISPE and ASTM
Experience with validation and qualification of complex equipment and systems
Experience drafting, reviewing, executing, and approving validation protocols and reports
Experience supporting validation activities in a regulated pharmaceutical or biotech environment
Experience with change controls, deviations, CAPAs, investigations, and risk assessments
Preferred Skills & Background
Biopharmaceutical, biotech, or pharmaceutical manufacturing experience
Experience with aseptic processing
Experience with cell culture
Experience with protein purification
Process validation experience
21 CFR Part 11 compliance experience
Validation of computerized systems
Continuous improvement and quality systems enhancement
Quality Risk Management expertise
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 + 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…