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 & ExperienceBachelor's degree in a related scientific field3-5 years of instrument lifecycle maintenanceStrong understanding of cGMP, GLP, and familiarity with 21 CFR Part 11 requirementsEffective time management and ability to meet deadlines consistentlyContinuous improvement mindset with strong problem-solving capabilitiesExperience with the following systems is a plus:PerkinElmer HPLC / TotalChromWaters HPLC / UPLC / Empower Essential Duties & Responsibilities Instrumentation & Equipment ManagementMaintain and oversee analytical instruments and laboratory equipmentTroubleshoot, repair, and coordinate servicing of analytical instrumentsMaintain work orders for instrument repairs and service activitiesManage instrument asset lifecycle and equipment recordsNotify QC management of instrument downtime or critical issues Calibration, Qualification & ValidationPrepare and maintain:Calibration SOPsPreventive Maintenance SOPsOperational SOPsDevelop and execute:IQ (Installation Qualification)OQ (Operational Qualification)PQ (Performance Qualification) protocolsMaintain the instrument quality program, including:CalibrationPreventive maintenanceIQ/OQ/PQ activities Compliance & DocumentationEnsure all documentation, logs, protocols, and records comply with FDA GMP requirementsCoordinate with QA on change controls (CRs), deviations, investigations, and CAPAs related to analytical instrumentsDraft, review, and approve Standard Operating Procedures (SOPs)Review instrument and equipment logbooks for accuracy and complianceEnsure laboratory activities and generated data comply with cGMP standards Vendor & Project CoordinationManage scheduling for instrument calibration and preventive maintenance activitiesServe as the primary contact for external vendors and service providersCoordinate repairs, qualifications, and maintenance with manufacturers and third-party vendorsObtain quotes for repairs, qualifications, calibrations, preventive maintenance, parts, and laborSupport and manage capital projects related to laboratory instrumentation Continuous Improvement & SafetyRecommend and implement methods to improve product quality and operational efficiencyParticipate in training and professional development activitiesPromote and maintain a safe, clean, and compliant laboratory environmentPerform additional duties as assigned INDBH #LI-AR1