GMP Facilities Engineer: Calibration & Maintenance (Onsite)

Pioneer GMP Consulting; Boston (MA); On-site; USD 100,000 - 150,000; Full time

Benefits offered by this job

Medical insurance (50% company-paid)

Vision insurance

Life insurance $100,000

Direct access to Pioneer leadership

Opportunities on high‑impact clientEng

Job summary

Pioneer GMP Consulting is seeking a Facilities Engineer to support calibration, maintenance, and facility operations for a biotechnology manufacturing organization in the Cambridge/Boston area.

You will perform calibrations, oversee vendors, and ensure GMP documentation remains complete, traceable, and inspection‑ready. This hands‑on role requires extensive work in GMP manufacturing, mechanical and utility areas, with onsite duties in Cambridge/Boston.

Qualifications

• Five to eight years of Facilities Engineering, Facilities Maintenance, Metrology, Calibration, Maintenance and Reliability, or related experience in GMP pharmaceutical or biotechnology manufacturing.
• Strong working experience with SAP Plant Maintenance, including creating, managing, documenting, and closing work orders.
• Strong knowledge of cGMP requirements, good documentation practices, and maintenance-record management.

Responsibilities

• Perform or oversee a high volume of calibration activities for GMP instruments, equipment, utilities, and facility systems
• Coordinate, supervise, and verify work performed by calibration vendors and third‑party service providers
• Support preventive maintenance, corrective maintenance, troubleshooting, and equipment‑repair activities
• Review calibration results, tolerances, as‑found and as‑left data, certificates, service reports, and supporting documentation
• Identify and elevate out‑of‑tolerance conditions, failed calibrations, overdue activities, recurring issues, and potential product or process impacts
• Support investigations, deviations, impact assessments, CAPAs, and follow‑up activities related to calibration or maintenance findings
• Create, plan, schedule, manage, and close work orders in SAP Plant Maintenance
• Maintain complete and accurate equipment history within SAP or other approved systems
• Perform field walkdowns, equipment inspections, maintenance verifications, and post‑work reviews
• Coordinate daily work with Facilities, Engineering, Maintenance, Metrology, Manufacturing, Quality, Validation, Automation, and system owners
• Monitor vendor performance, scheduling, documentation quality, safety practices, and compliance with client procedures
• Communicate work status, scheduling constraints, equipment risks, documentation gaps, and potential delays
• Support maintenance planning, equipment‑reliability initiatives, calibration‑program improvements, and inspection readiness
• Maintain complete, accurate, traceable, and inspection‑ready GMP documentation
• Represent Pioneer with professionalism, technical credibility, sound judgment, and accountability

Skills

Calibration expertise

Maintenance execution

GMP documentation

Vendor supervision

Field troubleshooting

Education

Bachelor's degree in engineering

Tools

SAP Plant Maintenance

Job description

Pioneer GMP Consulting is seeking a Facilities Engineer to support calibration, maintenance, and facility operations for a biotechnology manufacturing organization in the Cambridge/Boston area.

You will perform calibrations, oversee vendors, and ensure GMP documentation remains complete, traceable, and inspection‑ready. This hands‑on role requires extensive work in GMP manufacturing, mechanical and utility areas, with onsite duties in Cambridge/Boston.