Quality Engineer Jobs at Thermo Fisher Scientific with Visa Sponsorship
Quality Engineer roles at Thermo Fisher Scientific sit at the intersection of regulatory compliance and scientific manufacturing, covering everything from incoming inspection to CAPA management across life sciences and diagnostics. Thermo Fisher has a consistent track record of sponsoring international candidates for quality-focused engineering positions.
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Get Access To All JobsWork Schedule
Standard (Mon-Fri)
Environmental Conditions
- Able to lift 40 lbs. without assistance
- Adherence to all Good Manufacturing Practices (GMP) Safety Standards
- Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc. allowed
- Office
- Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Join our QA Validation team at Thermo Fisher Scientific, where you'll contribute to global healthcare and scientific advancement. As a Staff Validation Engineer, you'll lead validation activities for critical systems, equipment, and processes that enable the development and manufacturing of therapies.
Working in a GMP environment, you'll develop and implement comprehensive validation strategies aligned with regulatory requirements and corporate standards. You'll collaborate with cross-functional teams to ensure the successful qualification of facilities, utilities, manufacturing equipment, and computerized systems throughout their lifecycle.
Your expertise will be vital in maintaining compliance, driving continuous improvement, and serving as a technical subject matter expert during audits and investigations. You'll have opportunities to mentor team members while working on diverse projects ranging from new product introductions to complex system validations.
REQUIREMENTS
- 5 or more years of medical device experience
- Expert knowledge of cGMP regulations, GAMP 5, 21 CFR Part 11, and international regulatory requirements
- Strong experience with validation lifecycle documentation including risk assessments, validation plans, IQ/OQ/PQ protocols, and summary reports
- Demonstrated expertise in computerized system validation and data integrity requirements
- Experience with manufacturing equipment, utilities, and facility qualification
- Proven project management skills and ability to lead multiple concurrent validation projects
- Strong analytical and problem-solving capabilities
- Excellence in technical writing and documentation
- Strong communication and interpersonal skills
- Ability to influence and coordinate activities across multiple departments
- Proficiency with validation tools and standard office software
- Experience mentoring validation staff
- Physical ability to work in both office and manufacturing environments
Education:
- Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in validation experience in pharmaceutical/biotech manufacturing or related GMP environment
- Preferred Fields of Study: Engineering, Science, Biotechnology, or related technical field
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
- Able to lift 40 lbs. without assistance
- Adherence to all Good Manufacturing Practices (GMP) Safety Standards
- Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc. allowed
- Office
- Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Join our QA Validation team at Thermo Fisher Scientific, where you'll contribute to global healthcare and scientific advancement. As a Staff Validation Engineer, you'll lead validation activities for critical systems, equipment, and processes that enable the development and manufacturing of therapies.
Working in a GMP environment, you'll develop and implement comprehensive validation strategies aligned with regulatory requirements and corporate standards. You'll collaborate with cross-functional teams to ensure the successful qualification of facilities, utilities, manufacturing equipment, and computerized systems throughout their lifecycle.
Your expertise will be vital in maintaining compliance, driving continuous improvement, and serving as a technical subject matter expert during audits and investigations. You'll have opportunities to mentor team members while working on diverse projects ranging from new product introductions to complex system validations.
REQUIREMENTS
- 5 or more years of medical device experience
- Expert knowledge of cGMP regulations, GAMP 5, 21 CFR Part 11, and international regulatory requirements
- Strong experience with validation lifecycle documentation including risk assessments, validation plans, IQ/OQ/PQ protocols, and summary reports
- Demonstrated expertise in computerized system validation and data integrity requirements
- Experience with manufacturing equipment, utilities, and facility qualification
- Proven project management skills and ability to lead multiple concurrent validation projects
- Strong analytical and problem-solving capabilities
- Excellence in technical writing and documentation
- Strong communication and interpersonal skills
- Ability to influence and coordinate activities across multiple departments
- Proficiency with validation tools and standard office software
- Experience mentoring validation staff
- Physical ability to work in both office and manufacturing environments
Education:
- Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in validation experience in pharmaceutical/biotech manufacturing or related GMP environment
- Preferred Fields of Study: Engineering, Science, Biotechnology, or related technical field
See all 35+ Quality Engineer at Thermo Fisher Scientific jobs
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Get Access To All JobsTips for Finding Quality Engineer Jobs at Thermo Fisher Scientific Jobs
Align your credentials to FDA-regulated environments
Thermo Fisher's Quality Engineer roles in life sciences and diagnostics require familiarity with FDA 21 CFR Part 820 and ISO 13485. Documenting hands-on experience with these standards on your resume directly matches what hiring managers screen for.
Target sites with active manufacturing operations
Thermo Fisher's sponsorship activity for Quality Engineers clusters around its manufacturing and production facilities, not corporate offices. Search by location for sites in states like Massachusetts, Pennsylvania, and California where regulated manufacturing runs continuously.
Browse open Quality Engineer roles on Migrate Mate
Use Migrate Mate to filter Quality Engineer openings at Thermo Fisher Scientific by visa type, so you only see roles where sponsorship is confirmed. This removes the guesswork before you invest time in a full application.
Clarify your OPT or CPT timeline during screening
If you're on F-1 OPT, tell the recruiter your authorization end date and STEM extension eligibility upfront. Quality Engineer roles often take 60 to 90 days to fill, and Thermo Fisher needs that lead time to align filing deadlines with your start date.
Understand how TN status works for this role
Canadian and Mexican nationals can qualify for TN status under the engineer category if the Quality Engineer role requires a relevant bachelor's degree. Confirm with your hiring contact that the job description lists a specific engineering or science degree requirement, since TN adjudicators scrutinize this closely.
Confirm PERM sponsorship intent before accepting an offer
For Green Card sponsorship through EB-2 or EB-3, Thermo Fisher typically initiates PERM labor certification after you've established a performance record. Ask explicitly during offer negotiation whether the role is eligible for immigrant visa sponsorship and what the expected timeline looks like.
Quality Engineer at Thermo Fisher Scientific jobs are hiring across the US. Find yours.
Find Quality Engineer at Thermo Fisher Scientific JobsFrequently Asked Questions
Does Thermo Fisher Scientific sponsor H-1B visas for Quality Engineers?
Yes, Thermo Fisher Scientific sponsors H-1B visas for Quality Engineer positions. The company participates in the H-1B cap lottery each April and also files cap-exempt petitions for qualifying facilities. Because Quality Engineer roles require a specific technical degree, they generally satisfy USCIS specialty occupation requirements, which strengthens the petition.
Which visa types are commonly used for Quality Engineer roles at Thermo Fisher Scientific?
H-1B is the most common route for Quality Engineers at Thermo Fisher. F-1 OPT and CPT are used for recent graduates entering quality roles, with STEM OPT extensions available for qualifying degree holders. TN status is an option for Canadian and Mexican nationals in engineering classifications, and Green Card sponsorship via EB-2 or EB-3 is available for longer-term employees.
What qualifications does Thermo Fisher Scientific expect for Quality Engineer roles?
Most Quality Engineer postings at Thermo Fisher require a bachelor's degree in engineering, life sciences, or a closely related field. Practical experience with quality management systems, nonconformance handling, and root cause analysis is standard. Familiarity with ISO 13485, FDA 21 CFR Part 820, or GMP environments is a strong differentiator, particularly for roles in medical devices or bioproduction.
How do I apply for Quality Engineer jobs at Thermo Fisher Scientific?
You can search and apply through Thermo Fisher's careers portal directly. To focus specifically on roles that include visa sponsorship, use Migrate Mate to browse verified Quality Engineer openings at Thermo Fisher filtered by visa type. Applications typically require a resume, and some postings ask for a brief cover letter outlining relevant quality systems experience.
How do I manage the timing between my visa status and a Quality Engineer offer at Thermo Fisher Scientific?
Timing is the most common friction point for international candidates. If you're on OPT, confirm how many months of authorization remain and whether your degree qualifies for a STEM extension, which provides up to 24 additional months. For H-1B, petitions filed under the cap have an October 1 start date, so offers extended in spring need a gap plan or an OPT bridge. Raise this with your recruiter early.
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