Supervisor - Engineering, Validation

Catalent Pharma Solutions LLC; Kentucky; On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Competitive PTO

8 paid holidays

Medical, dental, and vision benefits (

Job summary

Catalent, Inc. in Madison, WI is seeking a Supervisor - Engineering, Validation to lead a team of validation professionals and ensure CQV programs meet regulatory standards.

You will oversee validation master plans, protocols, and reports, participate in audits, and drive continual improvement while partnering with QA, Manufacturing, Facilities, Engineering, and customers onsite. The role requires deep knowledge of FDA, ICH, EMA guidance, cGMP compliance, and change control processes, with

Qualifications

• Doctorate in STEM with 2+ years of related experience, or Master's with 4+ years, or Bachelor's with 5+ years.
• 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 cGMP.
• Knowledge of FDA, ICH, and EMA regulations.
• Ability to interpret regulatory guidance and validation requirements.
• Experience leading validation projects and initiatives.

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 Validation SME.
• Coordinate with QA, Manufacturing, Facilities, Engineering, and customers.
• Provide technical training and support.

Skills

CQV

Validation lifecycle management

Change Control

Requalification

Regulatory knowledge

Validation protocol/report writing

cGMP

Team leadership

Audits & inspections

Training and mentorship

Education

PhD in STEM

MS in STEM

BS in STEM

Job description

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 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 [e-mail]. 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.

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life‑cycle supply. With time‑tested experience in development sciences, delivery technologies, and multi‑modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life‑enhancing and life‑saving treatments for patients annually.