Engineer I Engineering, Validation

Catalents Madison Wisconsin site is a stateoftheart biologics development and manufacturing facility supporting customers from research through early and midstage clinical production. Located at 726 Heartland Trail in Madison the approximately 102700squarefoot GMP facility specializes in mammalian cell line engineering drug substance biomanufacturing and biopharmaceutical development utilizing flexible singleuse systems to enable rapid scaleup and customization. The site is home to Catalents proprietary GPEx and GPEx Lightning technologies which are used to generate highyielding mammalian cell lines for biologic therapies and supports production scales ranging from 50 to 4000 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 Catalents global biologics network and Wisconsins growing life sciences ecosystem.

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 crossfunctional teams to maintain high standards of quality and compliance. The successful candidate will contribute to continuous improvement and support the manufacture and release of highquality drug substances.

Shift: M-F 8am-5pm
Location: Madison WI
100% Onsite

• 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

• Bachelors degree in a technical field (Biology Biotechnology Engineering or related) with 7 years of relevant experience OR Masters 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

• 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

• 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 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.

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