Responsibilities
* own and manage the calibration and preventive maintenance program for gmp-critical equipment, ensuring accuracy, compliance, and timely execution.
* lead the induction of new controlled assets into the inventory and maintenance tracking systems.
* independently execute and improve daily, weekly, and monthly facilities operations to support manufacturing and laboratory readiness.
* develop, revise, and optimize calibration and preventive maintenance schedules in alignment with operational needs and regulatory standards.
* create and maintain accurate equipment documentation, including maintenance logs, procedures, and records.
* schedule and coordinate maintenance and calibration work with external vendors and internal teams, ensuring minimal disruption to production and lab activities.
* drive vendor qualification processes in partnership with quality assurance, including documentation review and audit support.
* collaborate with quality engineering to ensure timely completion and closure of equipment work orders, deviations, and change controls.
* act as a key contact for troubleshooting and resolving equipment issues, coordinating repairs and root cause analysis with vendors.
* initiate and support quality records, including deviations, capas, and change controls that impact gmp operations and facilities infrastructure.
* identify and recommend process improvements to enhance facility efficiency, compliance, and reliability.
requirements
* bachelor’s degree in engineering, life sciences, or related field preferred; equivalent hands‑on experience in gmp environments will be considered.
* 3–5+ years of experience in a gmp‑regulated facilities or equipment maintenance role, ideally in biotech or pharmaceutical manufacturing.
* strong understanding of gmp compliance, calibration standards, and equipment lifecycle management.
* demonstrated ability to manage vendors, prioritize competing tasks, and work independently with minimal supervision.
* proficiency in equipment tracking and maintenance systems; experience with cmms or qms software a plus.
* excellent written and verbal communication skills for clear documentation and cross‑functional collaboration.
* exceptional organizational skills and attention to detail, with a proactive and solutions‑oriented mindset.
work environment / physical demands:
* must be able to sit and stand for extended periods.
* must be able to lift/carry reports and materials up to 40 pounds, move about the office, communicate efficiently and effectively on the telephone or in person, and complete required paperwork.
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