Supervisor - Engineering, Validation
About The Position
The Supervisor - Engineering, Validation supports the Quality Assurance department at Catalent’s Madison, Wisconsin biologics development and manufacturing site. The role ensures compliance with FDA and other regulatory requirements by overseeing validation programs, including commissioning, qualification, and computer system validation, and maintaining systems in a validated state. The Supervisor leads a team of validation professionals and promotes quality, compliance, and continuous improvement across validation activities. The position is 100% onsite in Madison, Wisconsin, with a Monday–Friday, 8:00 a.m.–5:00 p.m. schedule. It involves 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. The role may require working in cleanroom environments as needed.
Requirements
- Doctorate degree in a STEM field and at least 2 years of related experience, or a Master’s degree in a STEM field and at least 4 years of related experience, or a Bachelor’s degree in a STEM field and 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.
- Frequent sitting, standing, walking, computer work, and document review; occasional bending, kneeling, crouching, and carrying materials; frequent lifting up to 10 pounds and occasional lifting up to 50 pounds.
- Ability to work within cleanroom environments as needed.
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.
- Lead validation projects and initiatives.
Benefits
- Competitive paid time off and 8 paid holidays.
- Medical, dental, and vision benefits effective on the first day 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
