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 a Supervisor - Engineering, Validation to join our team in Madison, WI. This role supports the Quality Assurance department, ensuring compliance with FDA and other regulatory requirements. The position oversees validation programs, including commissioning, qualification, and computer system validation, while maintaining systems in a validated state. The Supervisor will lead a team of validation professionals, ensuring quality, compliance, and continuous improvement across all validation activities.
Shift: M-F 8am-5pm
Location: Madison, WI
100% Onsite
The Role
Lead a team of Validation professionals.
Maintain Validation Master Plans.
Review and approve validation protocols and reports.
Support commissioning, qualification, and validation activities.
Review Change Controls.
Manage requalification programs.
Participate in audits and inspections.
Drive continuous improvement initiatives.
Serve as Validation Subject Matter Expert (SME).
Coordinate with Quality Assurance, Manufacturing, Facilities, Engineering, and customers.
Provide technical training and support.
The Candidate
Minimum Requirements
Doctorate degree in a STEM field with at least 2 years of related experience, or Master’s degree in a STEM field with at least 4 years of related experience, or Bachelor’s degree in a STEM field with at least 5 years of related experience.
0–2 years of leadership experience required.
Experience in Commissioning, Qualification, and Validation (CQV).
Knowledge of validation lifecycle management.
Experience with Change Control impact assessments.
Experience in requalification and periodic reviews.
Proficiency in validation protocol and report writing and execution.
Strong understanding of current Good Manufacturing Practices (cGMP).
Knowledge of FDA, ICH, and EMA regulations.
Ability to interpret regulatory guidance and validation requirements.
Experience leading validation projects and initiatives.
Frequent sitting, standing, walking, computer work, and document review.
Occasional bending, kneeling, crouching, and carrying materials.
Frequent lifting up to 10 lbs and occasional lifting up to 50 lbs.
Ability to work within cleanroom environments as needed.
Preferred Skills & Background
Experience in pharmaceutical manufacturing.
Experience in biologics manufacturing.
Experience in biotech manufacturing.
Experience in cell therapy or gene therapy environments.
Experience in Contract Development and Manufacturing Organizations (CDMOs) such as Catalent, Thermo Fisher Scientific, AbbVie, Fujifilm Diosynth, Lonza, CSL Behring, Pfizer, Amgen, Lilly, or Genentech.
Experience supporting biologics operations involving manufacturing processes and validated systems.
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…