Calibration Technician - Pharmaceutical Manufacturing
15 days ago
Warren
Job Description SOKOL GxP Services is seeking a hands-on Calibration Technician to support laboratory and manufacturing equipment within a GMP-regulated pharmaceutical and clinical manufacturing environment in Warren, NJ. This position focuses on calibration, preventive maintenance, requalification of temperature-controlled equipment, and ensuring compliance with FDA regulations, cGMP standards, and ALCOA+ data integrity principles. Key Responsibilities • Perform equipment calibration, preventive maintenance (PM), troubleshooting, and performance verification using CMMS systems (e.g., Maximo or Blue Mountain), • Execute requalification of Controlled Temperature Units (refrigerators, freezers including -20°ree;C / -80°ree;C, incubators, cryotanks, cryopods, storage rooms), • Review and approve vendor calibration and maintenance documentation, • Enter and maintain records in CMMS systems, • Escort and supervise vendors performing calibration and repair services, • Support deviations, investigations, and CAPA activities related to calibration, • Author and revise calibration and maintenance SOPs, • Maintain compliance with cGMP, Good Documentation Practices, and ALCOA+ principles, • Support audit readiness activities, • Perform equipment inventory and assist with planning/scheduling Requirements • Minimum 3 years of experience in an FDA-regulated pharmaceutical or biotech environment, • Hands-on experience calibrating laboratory or manufacturing equipment, • Experience working with CMMS systems (Maximo, Blue Mountain, or similar), • Strong understanding of cGMP and documentation standards, • Ability to troubleshoot and work independently, • Proficiency in Microsoft Office High School Diploma, Associate’s, or Bachelor’s degree accepted. Preferred Experience • Temperature mapping / controlled temperature unit requalification, • Experience in clinical manufacturing environments, • Experience supporting deviations and investigations Work Environment • Laboratory and manufacturing settings (PPE required), • May support multiple local sites, • Occasional lifting up to 25 lbs, • On-call support as required Benefits • $22.42 - $28.48 an hour, • Health, dental, and vision insurance, • 401(k) plan with company match, • Paid company holidays, • Interest free relocation assistance loan, • Continuous professional development and training opportunities through SOKOL GxP Academy