Supervisor - Engineering, Validation
About The Position
The Supervisor - Engineering, Validation supports the Quality Assurance department at Catalent’s Madison, Wisconsin site, a biologics development and manufacturing facility. The role ensures compliance with FDA and other regulatory requirements, oversees validation programs—including commissioning, qualification, and computer system validation—and maintains systems in a validated state. The Supervisor leads a team of validation professionals and promotes quality, compliance, and continuous improvement across validation activities. This is a 100% onsite position in Madison, Wisconsin, with a Monday–Friday, 8:00 a.m.–5:00 p.m. schedule. The position requires frequent sitting, standing, walking, computer work, and document review; occasional bending, kneeling, crouching, and carrying materials; frequent lifting of up to 10 pounds and occasional lifting of up to 50 pounds; and the ability to work in cleanroom environments as needed.
Requirements
- Doctorate degree in a STEM field with at least 2 years of related experience, or a Master’s degree in a STEM field with at least 4 years of related experience, or a Bachelor’s degree in a STEM field with at least 5 years of related experience.
- 0–2 years of leadership experience.
- 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.
- Ability to work within cleanroom environments as needed.
- Ability to meet the stated physical demands, including frequent lifting up to 10 pounds and occasional lifting up to 50 pounds.
Nice To Haves
- 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.
Responsibilities
- 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 the Validation Subject Matter Expert (SME).
- Coordinate with Quality Assurance, Manufacturing, Facilities, Engineering, and customers.
- Provide technical training and support.
Benefits
- Competitive paid time off.
- 8 paid holidays.
- Medical, dental, and vision benefits effective day one of employment.
- Tuition reimbursement.
- Defined career path and annual performance review and feedback process.
- Potential for career growth on an expanding team.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
