Facilities Associate II / III

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

• High school diploma or GED required. Bachelor's degree preferred, or equivalent relevant GMP experience in lieu of a degree
• 3+ years of experience in a highly regulated facilities (GMP/ISO) 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.