GMP Facilities Engineer: Calibration & Maintenance

BioTalent; Boston (MA); On-site; USD 90,000 - 140,000; Full time

Job summary

BioTalent is seeking a hands-on Facilities Engineer in the Greater Boston area to support daily GMP operations, calibration, maintenance, and facility systems. The role emphasizes on-site engagement with critical equipment and daily operations in a regulated setting.

The position focuses on hands-on calibration, preventive maintenance, troubleshooting of autoclaves and HVAC, and supporting qualification/validation activities.

Qualifications

• 5–10 years in facilities engineering, maintenance, metrology or calibration in pharma/life sciences.
• Hands-on metrology/calibration experience in a regulated GMP environment.
• Experience maintaining and troubleshooting autoclaves.
• Experience supporting autoclave qualification activities.
• Knowledge of facility systems including HVAC.
• Experience using CMMS platforms such as Blue Mountain or SAP.
• Strong GMP documentation experience for maintenance, calibration and work orders.
• Proven track record with preventive and corrective maintenance programs.
• Excellent troubleshooting and problem-solving skills.
• Ability to perform in a fast-paced manufacturing environment.

Responsibilities

• Perform calibration, maintenance, troubleshooting, and repair activities on GMP manufacturing and facility equipment.
• Execute preventive and corrective maintenance activities in support of operational reliability.
• Support calibration programs for critical instruments and process equipment.
• Maintain and troubleshoot autoclaves, including support of qualification and validation activities.
• Support facility operations, including HVAC systems and related utility equipment.
• Create, execute, and maintain GMP‑compliant maintenance, calibration, and work‑order documentation.
• Utilize CMMS systems such as Blue Mountain, SAP, or equivalent platforms to manage maintenance and calibration activities.
• Investigate equipment issues, identify root causes, and implement corrective actions.
• Coordinate with operations, engineering, quality, and validation teams to ensure equipment remains in a qualified state.
• Support regulatory inspections, audits, and quality initiatives as needed.
• Coordinate with external service providers and equipment vendors when required.
• Provide technical input for facility upgrades and capital projects as needed.

Skills

Facilities Engineering

Maintenance

Calibration

GMP Compliance

Metrology

Autoclaves

HVAC

CMMS

Blue Mountain

SAP

Tools

Blue Mountain

SAP

Job description

BioTalent is seeking a hands-on Facilities Engineer in the Greater Boston area to support daily GMP operations, calibration, maintenance, and facility systems. The role emphasizes on-site engagement with critical equipment and daily operations in a regulated setting.

The position focuses on hands-on calibration, preventive maintenance, troubleshooting of autoclaves and HVAC, and supporting qualification/validation activities.