OPT Engineering Supervisor Jobs
Engineering Supervisor jobs on OPT require demonstrating both technical depth and team leadership, which strengthens your H-1B visa sponsorship case. Most roles fall under specialty occupation, making them well-suited for STEM OPT extensions. Employers typically expect a bachelor's degree or higher in engineering alongside direct supervisory experience.
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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 OPT Engineering Supervisor Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new OPT Engineering Supervisor Jobs.
Get Access To All JobsTips for Finding OPT Sponsorship in Engineering Supervisor
Target companies with established H-1B sponsorship histories
Manufacturing firms, infrastructure contractors, and engineering consultancies file H-1B visa petitions regularly for supervisory roles. Prioritize employers with consistent sponsorship track records, as Engineering Supervisor positions are commonly approved as specialty occupations by USCIS.
Emphasize your technical engineering credentials upfront
Supervisory titles can raise questions about specialty occupation eligibility. Counter this by leading your resume with your engineering degree and hands-on technical work, making clear the role requires specific academic preparation, not just managerial experience.
Secure a STEM OPT extension before your 12 months expire
If your engineering degree qualifies under the STEM OPT list, apply for the 24-month extension early. This gives you a 36-month authorization window, significantly more time to find an Engineering Supervisor role and complete H-1B sponsorship.
Frame your leadership experience in technical terms
Employers and USCIS both need to see that your supervisory duties are grounded in engineering judgment. Describe decisions you made using technical expertise, such as overseeing safety protocols, reviewing designs, or resolving production engineering problems directly.
Ask directly about sponsorship timelines during interviews
Engineering Supervisor hiring cycles can move slowly at larger firms. Confirm early whether the employer can sponsor before your OPT expires and whether they use premium processing. This prevents investing weeks in a process that will not work out.
Highlight cross-functional project leadership on your application
Engineering Supervisors who can document managing budgets, coordinating with procurement, and leading cross-disciplinary teams are more compelling to sponsors. It signals the role justifies a specialty occupation petition, strengthening your employer's case with USCIS.
Engineering Supervisor OPT: Frequently Asked Questions
Do Engineering Supervisor roles qualify as specialty occupations for H-1B sponsorship?
Most Engineering Supervisor positions qualify as specialty occupations because they require at least a bachelor's degree in a specific engineering discipline. The key is that the supervisory duties must be grounded in technical engineering knowledge, not general management. If the job description ties leadership responsibilities to engineering expertise, the petition is on strong footing with USCIS.
Can I work as an Engineering Supervisor on OPT without a STEM extension?
Yes, you can work in this role during your initial 12-month OPT period. However, Engineering degrees typically appear on the STEM OPT designated degree list, so you should apply for the 24-month STEM extension as early as possible. The extension gives you significantly more runway to secure sponsorship and complete the H-1B petition process.
Where can I find Engineering Supervisor jobs that offer OPT sponsorship?
Migrate Mate is built specifically for F-1 OPT students and filters for employers willing to sponsor work visas. Searching there lets you focus on Engineering Supervisor roles at companies that have sponsored similar positions before, rather than spending time on applications at employers unlikely to support your authorization needs.
Will my supervisory title cause problems if my degree is in a specific engineering subfield?
It can, if the job description looks too generalist. The strongest OPT-to-H-1B cases for Engineering Supervisors show a direct connection between the engineering subfield of your degree and the technical decisions you make daily. Ask employers to keep the job description technically specific rather than defaulting to broad management language, which can complicate the specialty occupation determination.
What happens to my OPT authorization if I change employers while working as an Engineering Supervisor?
On standard OPT, you must report employer changes to your DSO within 10 days and update your SEVIS record. On STEM OPT, your new employer must also be enrolled in E-Verify and you must file a new Form I-983 training plan. Gaps in employment of more than 90 cumulative days during standard OPT, or 150 days during the STEM extension, can invalidate your authorization.