Thermo Fisher Scientific · 1 week ago
FSP - Sr. Instrument Qualification Specialist
New Brunswick, NJ
Full-time
Onsite
Mid, Senior Level
4+ years expThermo Fisher Scientific is a global leader in providing scientific solutions that improve health outcomes. The Sr. Instrument Qualification Specialist will manage the lifecycle of laboratory instruments, ensuring compliance with quality standards and overseeing instrument qualifications and maintenance activities.
BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
No H1B
Responsibilities
Manage laboratory instruments lifecycle, including qualification, data integrity, maintenance, repairs, and decommissioning activities
Oversee instrument qualifications, collaborate with instrument owners, vendors and IT teams to configure systems and complete data integrity risk assessments within required timelines
Independently engage with instrument vendors to understand data flow, software features, data file generation, and 21 CFR Part 11 compliance capabilities of application software
Prepare data integrity risk assessments, configuration specifications, and qualification summary reports to ensure compliance for instrument release
Facilitate calibration, performance verification / maintenance and decommissioning activities
Review vendor-executed calibration, maintenance, repair, and performance verification tasks to ensure compliance with quality standards
Manage schedules to ensure timely completion of qualification, calibration, performance verification testing, and maintenance operations
Partner with the quality assurance (QA) team to ensure the accuracy and completeness of documentation while addressing and resolving compliance issues
Administer user account management activities, including handling password resets and account configuration requests
Verify and execute data backup and restoration tasks according to defined processes
Ensure timely resolution of quality events to maintain compliance with procedures
Participate in the development, update, or revision of Standard Operating Procedures (SOPs)
Qualification
Required
Must be legally authorized to work in the United States without sponsorship
Must be able to pass a comprehensive background check, which includes a drug screening
Bachelor's degree in lab sciences such as Chemistry, Biology, Computer Science, or similar
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years')
OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 6+ years')
OR PhD and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 4+ years')
Proficient in instrument/equipment qualification, maintenance, and change control processes
Strong experience of 21 CFR Part 11 compliance pertaining to computer systems, including hardware, application software, and operating systems
Solid grasp of Data Integrity principles in a GxP environment
Experience in calibration, maintenance, and repair tasks for instrument lifecycle
Understanding of data file types generated by laboratory instruments and database structures
Demonstrated knowledge of compliance requirements under cGMP and FDA regulations, including Good Documentation Practices (GDP) and laboratory GMP principles
Excellent attention to detail, organizational skills, and ability to create technical documents
Proven ability to work independently and collaboratively, with a results-oriented mindset and the ability to drive projects to timely completion
Customer-focused attitude and commitment to meeting deadlines
Self-motivated with a proactive approach to problem-solving and task ownership
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner
Able to work upright and stationary and/or standing for typical working hours
Able to lift and move objects up to 25 pounds
Able to work in non-traditional work environments
Able to use and learn standard office equipment and technology with proficiency
May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities
Benefits
A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
Company
Thermo Fisher Scientific
Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$15.97BKey Investors
National Grid
2025-11-24Post Ipo Debt· $2.42B
2025-09-30Post Ipo Debt· $2.5B
2023-08-07Post Ipo Debt· $2.95B
Leadership Team
Stephen Williamson
Senior Vice President and Chief Financial Officer
Michel Lagarde
Chief Operating Officer
Recent News
CB Insights
2026-01-23
Company data provided by crunchbase