Associate Facility Engineer

Position Summary

The Associate Facility Engineer is an early-career role designed for a motivated, hands-on individual who is eager to learn and grow within a fast-moving biotech environment. Working under the guidance of the Facility Manager, this position contributes to the safe, reliable, and compliant operation of a facility that spans R&D laboratories, GMP pharmaceutical manufacturing, and shared operational spaces.

What You’ll Do

• Facility Buildout & Construction Support:

  • Participate in site walkthroughs with contractors, help track punch lists, and document observations.
  • Auxiliary in Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) activities under the direction of senior team members.
  • Support commissioning and qualification (CQV) activities, including helping execute protocols and organize turnover documentation.
  • Help review as-built drawings and O&M manuals to ensure accuracy as systems are handed over.
  • Auxiliary in organizing spare parts inventory as new equipment is installed and commissioned.

• Facility & Utility Systems:

  • Help monitor facility-wide utility systems including HVAC, chillers, boilers, compressed and medical gases, purified water, and building automation systems (BAS/BMS).
  • Conduct routine walkthroughs across manufacturing suites, research labs, mechanical rooms, and common areas to spot and report abnormalities, alarms, or equipment concerns.
  • Support environmental monitoring of controlled areas (temperature, humidity, differential pressure) and assist in calibration activities.
  • Learn and support the maintenance of facility systems in a validated and qualified state, with guidance from the Facility Manager.

• Preventive & Corrective Maintenance:

  • Perform preventive maintenance (PM) tasks according to approved schedules and SOPs.
  • Record maintenance activities accurately in the Computerized Maintenance Management System (CMMS) following GMP documentation principles.
  • Assist with corrective maintenance activities including identifying faults, sourcing parts, and supporting repairs.
  • Coordinate with and support external vendors during service visits and inspections.

• Compliance & Documentation:

  • Maintain accurate facility and maintenance records aligned with GMP documentation standards (ALCOA+).
  • Support change control, deviation write-ups, and CAPA activities related to facility systems, as directed.
  • Ensure the facility remains compliant with FDA, OSHA, EPA, and applicable local codes.
  • Assist during internal and external audits by gathering documentation and supporting facility walkthroughs.

• Environmental, Health & Safety:

  • Follow and promote safe work practices including lockout/tagout (LOTO), chemical hygiene, and biological safety protocols appropriate to each area.
  • Assist with safety inspections and support follow-up on corrective actions.
  • Develop awareness of radiation safety considerations applicable to a drug development environment, interfacing with the Radiation Safety Officer as directed.
  • Contribute to EHS recordkeeping and compliance documentation.

• Facility Security & Access Control:

  • Assist in administering access control systems, including badge setup, access level changes, and audit log reviews.
  • Coordinate with security vendors for maintenance and system updates.
  • Support CCTV and alarm system checks and maintenance activities.
  • Help maintain visitor management procedures, particularly during audits and inspections.

• Cross-Functional Support & Learning:

  • Respond to day-to-day facility requests from R&D and manufacturing teams, learning to triage and prioritize effectively.
  • Develop an understanding of how GMP manufacturing suites, research labs, and shared spaces interact and depend on one another.
  • Contribute to improvement projects and equipment upgrades as your knowledge and confidence grow.
  • Participate in vendor interactions and equipment reviews to build technical knowledge of facility systems.

Who You Are

• Curious and eager to learn – you ask good questions and take initiative to understand how things work.
• Detail-oriented and dependable – you follow through and document accurately.
• A team player who communicates clearly with scientists, operators, QA staff, and contractors alike.
• Comfortable with variety – you can shift from a scheduled maintenance task to an unexpected repair to a documentation request within the same morning.
• Excited by the opportunity to grow within a startup and take on more responsibility over time.
• Ability to stand, walk, climb ladders, and access mechanical and utility spaces.
• Ability to lift up to 40 lbs.
• Ability to work across cleanrooms, biological research labs, mechanical rooms, and outdoor areas.
• Must be able to distinguish colors (required for electrical and utility system work).