Factilities Engineer

Facilities Engineer – Calibration and Maintenance

Job Type: Full-Time

Work Type: 100% Onsite

Target

Start Date:

Late September/Early October

Initial Engagement: Minimum of 12–18 Months

Employment Type: Regular, Full-Time W2 Employee of Pioneer GMP Consulting

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

This is a highly hands‑on field position. You will spend significant time in GMP manufacturing, mechanical, and utility areas performing or overseeing calibrations, preventive maintenance, corrective maintenance, equipment inspections, and vendor‑executed work.

The position also requires strong GMP documentation and SAP Plant Maintenance experience. You will help ensure that work orders, calibration records, service reports, maintenance documentation, and equipment history are accurate, complete, traceable, and inspection‑ready.

Commissioning is being managed by separate construction and engineering partners. You may coordinate with these teams when their activities affect facility turnover or ongoing operations, but this role is primarily focused on calibration, maintenance, equipment support, vendor supervision, and the associated GMP documentation.

The initial client engagement is expected to last at least 12–18 months. This is a full‑time position with Pioneer—not employment limited to one client project. Future assignments may involve different clients, locations, responsibilities, work arrangements, or travel requirements.

• 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
• Ensure work‑order content accurately reflects the work performed, equipment status, required documentation, and final disposition
• Maintain complete and accurate equipment history within SAP or other approved systems
• Perform field walkdowns, equipment inspections, maintenance verifications, and post‑work reviews
• Confirm that equipment is appropriately documented and ready to return to service
• 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

• Five to eight years of Facilities Engineering, Facilities Maintenance, Metrology, Calibration, Maintenance and Reliability, or related experience in GMP pharmaceutical or biotechnology manufacturing
• Significant…