Instrument Service Engineer

Instrumentation Service Engineer $44-66/hour Contract to Hire Position Summary The Instrumentation Service Engineer is responsible for the maintenance, calibration, qualification, and safekeeping of laboratory equipment and analytical instruments used within the Quality Control (QC) laboratories. This role supports ongoing calibration, qualification, and preventive maintenance activities in coordination with approved vendors while ensuring compliance with FDA GMP regulations and internal quality standards. The ideal candidate will possess strong technical expertise in analytical instrumentation, cGMP/GLP compliance, and laboratory operations within the pharmaceutical industry. Qualifications Education & Experience Bachelor's degree in a related scientific field 3-5 years of instrument lifecycle maintenance Strong understanding of cGMP, GLP, and familiarity with 21 CFR Part 11 requirements Effective time management and ability to meet deadlines consistently Continuous improvement mindset with strong problem-solving capabilities Experience with the following systems is a plus: PerkinElmer HPLC / TotalChrom Waters

HPLC / UPLC

/ Empower Essential Duties & Responsibilities Instrumentation & Equipment Management Maintain and oversee analytical instruments and laboratory equipment Troubleshoot, repair, and coordinate servicing of analytical instruments Maintain work orders for instrument repairs and service activities Manage instrument asset lifecycle and equipment records Notify QC management of instrument downtime or critical issues Calibration, Qualification & Validation Prepare and maintain: Calibration SOPs Preventive Maintenance SOPs Operational SOPs Develop and execute: IQ (Installation Qualification) OQ (Operational Qualification) PQ (Performance Qualification) protocols Maintain the instrument quality program, including: Calibration Preventive maintenance

IQ/OQ/PQ

activities Compliance & Documentation Ensure all documentation, logs, protocols, and records comply with FDA GMP requirements Coordinate with QA on change controls (CRs), deviations, investigations, and CAPAs related to analytical instruments Draft, review, and approve Standard Operating Procedures (SOPs) Review instrument and equipment logbooks for accuracy and compliance Ensure laboratory activities and generated data comply with cGMP standards Vendor & Project Coordination Manage scheduling for instrument calibration and preventive maintenance activities Serve as the primary contact for external vendors and service providers Coordinate repairs, qualifications, and maintenance with manufacturers and third-party vendors Obtain quotes for repairs, qualifications, calibrations, preventive maintenance, parts, and labor Support and manage capital projects related to laboratory instrumentation Continuous Improvement & Safety Recommend and implement methods to improve product quality and operational efficiency Participate in training and professional development activities Promote and maintain a safe, clean, and compliant laboratory environment Perform additional duties as assigned INDBH #LI-AR1