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.
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Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing.
Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
The Process Validation Engineer will be responsible for drafting, reviewing, and overseeing the execution of process and cleaning validation documentation.
Responsibilities
- Draft and review process validation and cleaning validation protocols and reports, ensuring compliance with GMP regulations.
- Oversee and manage the execution of manufacturing validation activities, ensuring timelines and quality standards are met.
- Collaborate with cross-functional teams to ensure validation strategies align with production requirements and regulatory guidelines.
- Provide technical support to manufacturing during validation and qualification activities.
- Identify and assess risks, proposing corrective actions and improvements to enhance validation processes.
- Ensure compliance with all applicable regulatory requirements, including FDA, EMA, and ICH guidelines.
- Review and approve validation data and documentation to ensure accuracy and regulatory compliance.
- Participate in audits and inspections, providing validation documentation and responding to inquiries from regulatory agencies.
- Provide training and mentorship to employees on validation processes and GMP standards.
Requirements
- BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry
- Strong written and verbal communication skills to effectively interact with internal teams, management, and regulatory bodies.
- Excellent technical writing skills with high attention to detail
- Proficiency in Microsoft Word and Excel
- Ability to work across teams
- Experience in drafting and reviewing validation protocols and reports.
- Strong understanding of GMP regulations, validation principles, and industry best practices.
- Minimum 5 years of experience in GMP validation or a related field, with at least 3 years of GMP manufacturing experience preferred.
- Knowledge of process and cleaning validation activities, including test methods, execution, and data analysis.
- Excellent problem-solving skills and attention to detail.
- Strong written and verbal communication skills to effectively interact with internal teams, management, and regulatory bodies.
- Experience with regulatory submissions and/or inspections.
- Experience in a pharmaceutical or biopharmaceutical manufacturing environment.
- Experience working in a GMP setting
- Experience with controlled documentation
Preferred
- 8 years of experience in GMP validation or a related field
- Six Sigma or Lean certifications are a plus.
Arrowhead provides competitive salaries and an excellent benefit package.
Candidates must have current, valid authorization to work in the country where this role is located.
California Applicant Privacy Policy
Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing.
Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
The Process Validation Engineer will be responsible for drafting, reviewing, and overseeing the execution of process and cleaning validation documentation.
Responsibilities
- Draft and review process validation and cleaning validation protocols and reports, ensuring compliance with GMP regulations.
- Oversee and manage the execution of manufacturing validation activities, ensuring timelines and quality standards are met.
- Collaborate with cross-functional teams to ensure validation strategies align with production requirements and regulatory guidelines.
- Provide technical support to manufacturing during validation and qualification activities.
- Identify and assess risks, proposing corrective actions and improvements to enhance validation processes.
- Ensure compliance with all applicable regulatory requirements, including FDA, EMA, and ICH guidelines.
- Review and approve validation data and documentation to ensure accuracy and regulatory compliance.
- Participate in audits and inspections, providing validation documentation and responding to inquiries from regulatory agencies.
- Provide training and mentorship to employees on validation processes and GMP standards.
Requirements
- BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry
- Strong written and verbal communication skills to effectively interact with internal teams, management, and regulatory bodies.
- Excellent technical writing skills with high attention to detail
- Proficiency in Microsoft Word and Excel
- Ability to work across teams
- Experience in drafting and reviewing validation protocols and reports.
- Strong understanding of GMP regulations, validation principles, and industry best practices.
- Minimum 5 years of experience in GMP validation or a related field, with at least 3 years of GMP manufacturing experience preferred.
- Knowledge of process and cleaning validation activities, including test methods, execution, and data analysis.
- Excellent problem-solving skills and attention to detail.
- Strong written and verbal communication skills to effectively interact with internal teams, management, and regulatory bodies.
- Experience with regulatory submissions and/or inspections.
- Experience in a pharmaceutical or biopharmaceutical manufacturing environment.
- Experience working in a GMP setting
- Experience with controlled documentation
Preferred
- 8 years of experience in GMP validation or a related field
- Six Sigma or Lean certifications are a plus.
Arrowhead provides competitive salaries and an excellent benefit package.
Candidates must have current, valid authorization to work in the country where this role is located.
California Applicant Privacy Policy
See All 10 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 Brunswick, CAI, and Accuray and others right now, based on current listings on Migrate Mate as of September 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 Oshkosh 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 33% of validation engineer openings tied to Wisconsin are remote or hybrid as of September 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 10 Validation Engineer Jobs in Wisconsin
Find roles in Wisconsin that match your experience and apply in just a few clicks.
Find Validation Engineer Jobs