Position SummaryWe 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 CandidateMinimum 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.
