Engineer I - Engineering, Validation

Catalent Pharma Solutions LLC; Kentucky; On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Competitive PTO and 8 paid holidays

Benefits from day one (medical, dental

Tuition Reimbursement

Job summary

Catalent, Inc. in Madison, WI is seeking an Engineer I - Engineering, Validation to join our QA‑focused team on a 100% onsite basis.

The role supports validation activities to ensure compliance with regulatory standards and internal quality guidelines, overseeing validation programs, commissioning and qualification of equipment, and collaborating with cross‑functional teams to maintain high quality and compliance.

Qualifications

• Bachelor's degree in a technical field (Biology, Biotechnology, Engineering, or related) with 7+ years of relevant experience
• Strong knowledge of cGMP regulations
• Knowledge of validation standards including ISPE and ASTM
• Experience with validation and qualification of complex equipment and systems
• Experience drafting, reviewing, executing, and approving validation protocols and reports
• Experience supporting validation activities in a regulated pharmaceutical or biotech environment
• Experience with change controls, deviations, CAPAs, investigations, and risk assessments

Responsibilities

• Review and approve validation documents
• Support commissioning and qualification of equipment and utilities
• Lead validation activities for new equipment and systems
• Serve as QA subject matter expert for Validation and Risk Management
• Assess change controls for impact to validated systems
• Support audits and regulatory inspections
• Investigate deviations related to validation activities
• Maintain Validation Master Plan
• Partner with Manufacturing, Process Development, Facilities, Regulatory Affairs, and Quality teams
• Manage validation contractors when necessary
• Provide training and technical support

Skills

cGMP knowledge

Validation concepts

Risk assessment

Education

Bachelor's degree in a technical field

Master's degree in a technical field

Tools

ISPE standards

ASTM standards

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 an Engineer I - Engineering, Validation to join our team in Madison, WI. This role supports quality assurance and validation activities to ensure compliance with regulatory and internal quality standards. The position involves oversight of validation programs, commissioning and qualification of equipment, and collaboration with cross‑functional teams to maintain high standards of quality and compliance. The successful candidate will contribute to continuous improvement and support the manufacture and release of high‑quality drug substances. Shift: M-F 8am-5pm Location: Madison, WI 100% Onsite

The Role

• Review and approve validation documents
• Support commissioning and qualification of equipment and utilities
• Lead validation activities for new equipment and systems
• Serve as QA subject matter expert for Validation and Risk Management
• Assess change controls for impact to validated systems
• Support audits and regulatory inspections
• Investigate deviations related to validation activities
• Maintain Validation Master Plan
• Partner with Manufacturing, Process Development, Facilities, Regulatory Affairs, and Quality teams
• Manage validation contractors when necessary
• Provide training and technical support

The Candidate Minimum Requirements

• Bachelor's degree in a technical field (Biology, Biotechnology, Engineering, or related) with 7+ years of relevant experience OR Master's degree in a technical field with 4+ years of relevant experience
• Strong knowledge of cGMP regulations
• Knowledge of validation standards including ISPE and ASTM
• Experience with validation and qualification of complex equipment and systems
• Experience drafting, reviewing, executing, and approving validation protocols and reports
• Experience supporting validation activities in a regulated pharmaceutical or biotech environment
• Experience with change controls, deviations, CAPAs, investigations, and risk assessments

Preferred Skills & Background

• Biopharmaceutical, biotech, or pharmaceutical manufacturing experience
• Experience with aseptic processing
• Experience with cell culture
• Experience with protein purification
• Process validation experience
• 21 CFR Part 11 compliance experience
• Validation of computerized systems
• Continuous improvement and quality systems enhancement
• Quality Risk Management expertise

Why You Should Join Catalent

Competitive paid time off + 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.

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.