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 organization dedicated to preserving and bettering lives.
Competitive paid time off plus 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 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 DisabilityAccommodations@catalent.com. 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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