Senior Lab Instrumentation Engineer – Onsite, NJ

LabRulez; New Brunswick (NJ); On-site; USD 95,000 - 100,000; Full time

Benefits offered by this job

Healthcare

Annual bonus

401(k) plan

Job summary

Thermo Fisher Scientific is seeking a Laboratory Instrumentation Senior to manage instrument lifecycles, qualifications, and data integrity at a New Jersey site. You will coordinate with vendors, QA, and IT to ensure compliance with 21 CFR Part 11 and GDP/GMP standards.

The role requires a BS in a related field with 4–6 years of experience and a proactive, results-driven approach. Onsite work with competitive benefits and bonus eligibility is offered.

Qualifications

• Bachelor of Science in a related discipline with 4-6 years of experience.
• Knowledge of cGMP and FDA regulations, GDP, and GMP principles.
• Strong attention to detail and ability to produce technical documents.

Responsibilities

• Manage laboratory instruments lifecycle including qualification, data integrity, maintenance, repairs, and decommissioning.
• Oversee instrument qualifications and ensure data integrity within timelines.
• Engage with vendors to understand data flow, software features, and 21 CFR Part 11 capabilities.
• Prepare reports to ensure compliance for instrument release.
• Coordinate calibration, maintenance, and verification activities.
• Collaborate with QA to ensure documentation accuracy and resolve issues.
• Administer user accounts and data backup tasks.
• Ensure timely resolution of quality events and updates to SOPs.

Skills

Instrument qualification

Data integrity

21 CFR Part 11 compliance

Calibration/maintenance

GxP knowledge

Education

B.S. in chemistry/biology/computer science

4-6 years relevant experience

cGMP/FDA GDP knowledge

Job description

Thermo Fisher Scientific is seeking a Laboratory Instrumentation Senior to manage instrument lifecycles, qualifications, and data integrity at a New Jersey site. You will coordinate with vendors, QA, and IT to ensure compliance with 21 CFR Part 11 and GDP/GMP standards.

The role requires a BS in a related field with 4–6 years of experience and a proactive, results-driven approach. Onsite work with competitive benefits and bonus eligibility is offered.