GMP Facilities Engineer II - Reliability & Compliance

ElevateBio; Waltham (MA); On-site; USD 125,000 - 165,000; Full time

Job summary

ElevateBio is seeking a Facilities Engineer to support GMP facilities, utilities and infrastructure ensuring safe, compliant manufacturing operations in a regulated biotech setting.

Responsibilities include troubleshooting equipment and utility systems, supporting commissioning and validation, managing CAPAs and change controls, and coordinating with cross-functional teams to optimize asset performance and compliance.

Qualifications

• BS degree in mechanical/chemical/facilities/industrial engineering or equivalent.
• 5+ years in GMP biotech or FDA regulated environments.
• Strong organizational, independent and collaborative working style.
• Excellent interpersonal and verbal communication skills.
• Experience presenting Facilities Engineering in regulatory audits.

Responsibilities

• Maintain GMP facilities, utilities and infrastructure for safe, reliable manufacturing.
• Troubleshoot equipment and utility systems with root cause analysis and CAPA support.
• Support commissioning, validation and engineering change management lifecycles.
• Lead walkdowns of drawings and piping/ instrument diagrams for base builds.
• Manage maintenance programs, calibration and asset management in CMMS.
• Collaborate with Facilities, Validation, Quality and cross-functional teams.

Skills

GMP Biotech Experience

Regulatory Audits

Technical Writing

Verbal Communication

Collaboration

Education

BS Degree in Mechanical, Chemical, Facilities, Industrial Engineering or equivalent

Tools

CMMS

Job description

ElevateBio is seeking a Facilities Engineer to support GMP facilities, utilities and infrastructure ensuring safe, compliant manufacturing operations in a regulated biotech setting.

Responsibilities include troubleshooting equipment and utility systems, supporting commissioning and validation, managing CAPAs and change controls, and coordinating with cross-functional teams to optimize asset performance and compliance.