OPT Validation Engineer Jobs
Validation Engineer jobs are a strong fit for F-1 OPT students with degrees in biomedical engineering, chemical engineering, mechanical engineering, or a related field. Most roles qualify as STEM OPT, giving you up to three years of work authorization. Employers in pharma, biotech, and medical devices regularly sponsor H-1B visas for this role.
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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 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 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 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 190+ OPT Validation Engineer Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new OPT Validation Engineer Jobs.
Get Access To All JobsTips for Finding OPT Sponsorship as a Validation Engineer
Target regulated industries first
Pharmaceutical, biotech, and medical device companies hire Validation Engineers in volume and have established immigration programs. These employers understand visa timelines and are far more likely to sponsor OPT and H-1B than general manufacturing firms.
Confirm your role qualifies for STEM OPT
Validation Engineer positions tied to biomedical, chemical, or mechanical engineering degrees typically qualify for the 24-month STEM OPT extension. Verify your CIP code with your DSO before accepting an offer to protect your full authorization window.
Apply to employers with active H-1B history
Companies that have filed H-1B petitions for Validation Engineers in the past are your strongest leads. Prior filings signal an existing immigration process and legal support, which reduces delays and uncertainty when your OPT period ends.
Emphasize GMP and regulatory knowledge
Experience with Good Manufacturing Practice, FDA regulations, or ISO standards makes you a more compelling candidate and harder to replace. Employers are more willing to invest in sponsorship for candidates with specialized compliance knowledge that took time to develop.
Start your H-1B conversation at the offer stage
Ask about H-1B sponsorship before signing an offer letter, not months later. Frame it professionally by confirming the company has an immigration attorney on file and has sponsored roles at your level before. Early clarity prevents costly surprises.
Use contract-to-hire roles strategically
Staffing agencies sometimes place Validation Engineers in contract roles at large pharma or medical device companies. If the host company is the one filing your H-1B, confirm sponsorship terms in writing before starting. This path can work, but the details matter.
Validation Engineer OPT: Frequently Asked Questions
Do Validation Engineer jobs qualify for the STEM OPT extension?
Most Validation Engineer roles qualify for the 24-month STEM OPT extension if your degree is in biomedical engineering, chemical engineering, mechanical engineering, or a related STEM field. Your employer must be E-Verify enrolled, and your DSO must confirm your CIP code qualifies. If both conditions are met, you get up to three years of total OPT authorization.
Which industries hire the most Validation Engineers willing to sponsor OPT?
Pharmaceutical manufacturing, biotechnology, and medical device companies are the most consistent sponsors for Validation Engineers. These industries are heavily regulated and rely on qualified engineers to maintain FDA and ISO compliance, which makes them more willing to invest in sponsorship. Contract research organizations and drug delivery companies are also strong targets. You can browse OPT-friendly employers in these sectors on Migrate Mate.
What does a Validation Engineer typically do, and does the work qualify as a specialty occupation for H-1B?
Validation Engineers design and execute test protocols to confirm that equipment, processes, and systems meet regulatory and quality standards. The role typically requires a bachelor's degree or higher in a specific engineering discipline, which satisfies the H-1B specialty occupation requirement. USCIS has historically approved H-1B petitions for this title at regulated manufacturers, though the petition must clearly link your degree field to the job duties.
Can I work as a Validation Engineer through a staffing agency on OPT?
Yes, but the arrangement requires care. If a staffing agency places you at a client site, the agency is technically your employer of record and the one responsible for OPT compliance and any future H-1B filing. Confirm that the agency is E-Verify enrolled for STEM OPT eligibility, and get any H-1B sponsorship commitments in writing before you start. Some agencies do sponsor, but many do not.
How early should I apply for Validation Engineer jobs as an F-1 student?
Apply at least three to four months before your program end date to leave room for employer onboarding, OPT card processing, and any delays. If you need the STEM extension, your application must be filed before your initial OPT expires. Validation roles in regulated industries often have longer hiring cycles due to background checks and compliance reviews, so earlier is better.