Validation Engineer Jobs in Wisconsin
Validation Engineer jobs in Wisconsin are concentrated in the Milwaukee metro, the Madison corridor, and the Fox Valley region, where life sciences, medical devices, pharmaceutical manufacturing, and industrial automation drive consistent demand at every level from entry-level process validation roles to senior CSV and equipment qualification specialists. Large employers with established Wisconsin footprints, including GE Healthcare, Abbott, and Exact Sciences, maintain ongoing validation engineering teams here. Computer system validation, process validation, and IQ/OQ/PQ protocol development are the most in-demand specialties across the state. See the openings below and apply to the ones that match your experience.
Find Validation Engineer JobsOverview
Showing 5 of 12+ Validation Engineer jobs
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.
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 DisabilityAccommodations@catalent.com. 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.
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.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.
Volunteer Work Disclosure: Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis.
Massachusetts Lie Detector Test Notice: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.
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.
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 DisabilityAccommodations@catalent.com. 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.
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.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.
Volunteer Work Disclosure: Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis.
Massachusetts Lie Detector Test Notice: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.
See All 12 Validation Engineer Jobs in Wisconsin
Find roles in Wisconsin that match your experience and apply in just a few clicks.
Find Validation Engineer JobsValidation Engineer Jobs by City in Wisconsin
Where Wisconsin roles are concentrated, by current openings.
Validation Engineer Job Market in Wisconsin
A snapshot from current Wisconsin openings, updated as new roles post.
Who's Hiring
Top Industries Hiring
- Consulting & Professional Services
What Wisconsin Employers Look For
The qualifications that appear most often in validation engineer jobs across Wisconsin.
- Bachelor's degree in engineering, life sciences, or a closely related technical field
- Hands-on experience with IQ, OQ, and PQ validation protocols in regulated environments
- Working knowledge of FDA 21 CFR Part 11, Part 820, or relevant GMP regulations
- Proficiency in writing and executing validation documentation and change control procedures
- Experience with computer system validation or automated manufacturing equipment qualifications
- Familiarity with risk assessment methodologies such as FMEA in a Wisconsin-regulated facility
Validation Engineer Jobs in Wisconsin: Frequently Asked Questions
How do you become a validation engineer in Wisconsin?
Most validation engineers in Wisconsin enter the field with a bachelor's degree in engineering, chemistry, biology, or a related discipline, followed by experience in a regulated manufacturing environment such as medical devices, pharmaceuticals, or food processing. Wisconsin does not require a state-issued license specific to validation engineering. Employers in sectors regulated by the FDA or USDA often prefer candidates who have completed internal or employer-sponsored training on GMP practices and validation frameworks before their first assignment.
Which companies hire validation engineers in Wisconsin?
Wisconsin validation engineer roles are posted by Katalyst Healthcares & Life Sciences, CAI, and Rehlko and others right now, based on current listings on Migrate Mate as of November 2026. The heaviest concentration of Wisconsin employers in this field is in medical device manufacturing, pharmaceutical production, and industrial automation, particularly around Milwaukee, Madison, and the Fox Valley corridor.
Which Wisconsin cities have the most validation engineer jobs?
Madison, Kenosha, and Beloit account for the largest share of validation engineer openings in Wisconsin. Milwaukee leads because of its dense cluster of medical device and industrial manufacturing employers, Madison draws openings tied to biotech and pharmaceutical companies near the university research corridor, and smaller markets like Green Bay and the Fox Valley reflect the region's concentration of food processing and specialty manufacturing facilities that operate under FDA or USDA oversight.
Are there remote validation engineer jobs in Wisconsin?
Yes, but they're rare. Validation engineering is fundamentally a hands-on discipline tied to physical equipment, production lines, and regulated facilities, so most roles require on-site presence at least during protocol execution. About 50% of validation engineer openings tied to Wisconsin are remote or hybrid as of November 2026, and those tend to cover documentation-heavy phases such as computer system validation, protocol writing, or regulatory submission support rather than on-floor qualification work.
How can I get hired as a validation engineer in Wisconsin with little or no experience?
The most realistic entry path is a quality, manufacturing, or laboratory technician role at a regulated Wisconsin facility, which builds direct exposure to SOPs, change control, and GMP documentation. Large Wisconsin employers in medical devices and pharmaceuticals, including those in the Milwaukee and Madison markets, regularly hire new graduates into quality assurance or manufacturing associate roles that rotate into validation projects. Completing an internal GMP or validation fundamentals training, earning an ASQ Certified Quality Technician credential, or contributing to a validation project during a co-op strengthens a candidate's profile significantly.
Where can I find and apply to validation engineer jobs in Wisconsin?
You can find and apply to validation engineer jobs in Wisconsin on Migrate Mate, which lists current Wisconsin openings updated regularly. Search the listings to find roles that match your experience, seniority level, and preferred location within the state, then apply directly to the ones that fit.
See All 12 Validation Engineer Jobs in Wisconsin
Find roles in Wisconsin that match your experience and apply in just a few clicks.
Find Validation Engineer Jobs