OPT Validation Specialist Jobs
Validation Specialist roles are a strong fit for F-1 OPT students with backgrounds in engineering, life sciences, or quality assurance. Most positions qualify as STEM OPT-eligible, giving you up to 36 months of work authorization. Employers in pharma, biotech, and medical device manufacturing regularly hire OPT candidates for these roles.
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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 Specialist Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new OPT Validation Specialist Jobs.
Get Access To All JobsTips for Finding OPT Sponsorship as a Validation Specialist
Target STEM-designated programs
Validation Specialist roles typically fall under STEM OPT CIP codes in engineering or life sciences. Confirm your degree's CIP code qualifies before applying, since STEM OPT eligibility determines whether you get 12 or 36 months of authorized work.
Highlight GMP and regulatory knowledge
Employers in pharma and medical devices prioritize candidates who understand FDA regulations, GMP compliance, and validation protocols like IQ, OQ, and PQ. Listing these credentials signals you can contribute immediately without an extended onboarding period.
Apply to large regulated-industry employers first
Companies in pharmaceutical manufacturing, biotech, and medical devices are accustomed to OPT and H-1B visa sponsorship. Mid-to-large employers in these sectors have established HR processes for work authorization and are far less likely to reject OPT applicants outright.
Address your timeline proactively
Validation roles often involve long-term projects spanning 12 to 24 months. Mentioning your STEM OPT eligibility early reassures employers that your authorization covers the project lifecycle, reducing hesitation about hiring someone mid-process.
Get your STEM OPT extension application in early
File your STEM OPT extension at least 90 days before your initial OPT expires. Late filing can create a work authorization gap, which is especially problematic if you are mid-validation project and your employer depends on your continued availability.
Frame contract and consulting roles as valid options
Many Validation Specialist positions are filled through life sciences staffing firms on contract terms. These arrangements are fully compatible with OPT as long as your DSO approves the employer and the role aligns with your degree field.
Validation Specialist OPT: Frequently Asked Questions
Do Validation Specialist jobs qualify for STEM OPT extension?
Most Validation Specialist positions qualify for the 24-month STEM OPT extension, provided your degree is in a STEM-designated field such as biomedical engineering, chemical engineering, or a related life science. The role must also be directly related to your degree program. Confirm your CIP code with your DSO before applying to roles so you know your full authorization window.
Will employers in pharma and biotech sponsor OPT students for Validation Specialist roles?
Yes. Pharmaceutical manufacturers, biotech firms, and medical device companies are among the most OPT-friendly employers for this role because they have established immigration compliance processes and regularly file H-1B petitions. Companies like these are accustomed to work authorization documentation and are far less likely to screen out OPT candidates than employers in unregulated industries. Browse current openings on Migrate Mate to find employers actively hiring OPT students.
What is the typical OPT work authorization period for a Validation Specialist role?
Initial post-completion OPT gives you 12 months of work authorization. If your degree qualifies as STEM-designated, you can apply for a 24-month extension, for a total of 36 months. Most multi-phase validation projects run 12 to 24 months, so securing your STEM OPT extension well before the initial period expires is important for maintaining continuous authorization throughout the engagement.
Can I work as a Validation Specialist through a staffing agency on OPT?
Yes, contract placements through life sciences staffing firms are compatible with OPT, but there are conditions. The staffing agency must function as your employer of record, your DSO must approve the arrangement, and the work must be directly related to your degree. Avoid arrangements structured as independent contracting, since self-employment on OPT is subject to strict DSO oversight and documentation requirements.
What documentation should I prepare before applying for Validation Specialist roles on OPT?
Have your EAD card, current I-20 with OPT authorization dates, and university transcripts ready to share with hiring managers. For STEM-heavy roles, a brief summary of relevant coursework or thesis work in quality systems or regulatory affairs can help. If your STEM OPT extension is pending, carry your extension receipt notice alongside your original EAD, since the two together demonstrate continued work authorization during the processing period.