Senior Lab Support Engineer

Thermo Fisher Scientific Inc

Thermo Fisher Scientific seeks an Instrument Qualification Specialist to manage laboratory instrument lifecycle, including qualification, maintenance, and compliance activities at a customer site in New Brunswick, NJ. The role involves overseeing instrument configurations, data integrity assessments, vendor coordination, and regulatory compliance documentation.

Responsibilities

Manage instrument lifecycle including qualification, maintenance, repairs, and decommissioning
Oversee instrument qualifications and collaborate with owners, vendors, and IT teams on system configuration
Prepare data integrity risk assessments, configuration specifications, and qualification reports
Engage with vendors to understand data flow, software capabilities, and 21 CFR Part 11 compliance
Facilitate calibration, performance verification, and maintenance activities while reviewing vendor work for compliance

Requirements

Bachelor of Science in chemistry, biology, computer science, or related field
4-6 years of instrument qualification and lifecycle management experience
Knowledge of cGMP, FDA regulations, and Good Documentation Practices
Strong expertise in 21 CFR Part 11 compliance for computer systems
Proficiency with data integrity principles in GxP environments
Experience with calibration, maintenance, and repair processes for laboratory instruments
Ability to work independently and collaboratively with strong organizational skills

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Vacancy posted 2 days ago

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