Engineer I - Engineering, Validation

Catalent, Inc.; Madison (WI); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Tuition Reimbursement

Benefits from day one

Job summary

Catalent, Inc. is seeking an Engineer I - Engineering, Validation in Madison, WI to uphold QA and validation standards across equipment and systems. You will lead validation activities, collaborate with cross-functional teams, and ensure compliant documentation and processes.

The role emphasizes oversight of validation programs, commissioning, qualification, and continuous improvement within a 100% onsite environment. Strong background in cGMP and validation methodologies is required.

Qualifications

• Bachelor's or Master’s in a technical field with relevant validation experience.
• Strong knowledge of cGMPs and validation standards (ISPE/ASTM).
• Experience drafting, reviewing, executing, and approving validation protocols and reports.
• Experience supporting validation activities in regulated pharma/biotech environments.
• 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 experience

Change controls

CAPAs

Risk assessments

Documentation

Education

Bachelor's degree in technical field

Master's degree in technical field

Tools

ISPE standards

ASTM standards

21 CFR Part 11

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.
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

• 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 + 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.
Catalent is an Equal Opportunity Employer, including disability and veterans.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
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