GMP Facilities Engineer - Onsite Consulting

Pioneer GMP Consulting

Cambridge, Northern (MA, KY)

Hybrid

USD 90,000 - 120,000

Full time

9 days ago

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Job summary

Pioneer GMP Consulting is seeking a Facilities Engineer to support pharmaceutical and biotech manufacturing operations in the Cambridge/Boston area. The role is hands-on, combining field execution with GMP documentation responsibilities, including maintenance planning, calibration, and vendor coordination.

You will work embedded within client operations while collaborating with Facilities, Engineering, Manufacturing, Validation, and Quality teams to ensure cGMP compliance and reliable equipment

Qualifications

  • 5–8 years in GMP facilities engineering or maintenance in pharma/biotech.
  • Hands-on calibration, preventive and corrective maintenance experience.
  • Experience coordinating maintenance contractors or third-party providers.
  • Knowledge of GMP documentation practices and CMMS usage (SAP PM).

Responsibilities

  • Support day-to-day Facilities Engineering activities within GMP-regulated manufacturing environments.
  • Perform and oversee calibration, preventive maintenance, corrective maintenance, and equipment support activities.
  • Coordinate and supervise third-party vendors performing maintenance, calibration, and facility services.
  • Support maintenance planning, scheduling, and execution to ensure equipment reliability and regulatory compliance.
  • Create, review, and manage GMP maintenance documentation, including work orders, maintenance records, and equipment history.
  • Utilize SAP Plant Maintenance (PM) to initiate, manage, and close work orders while maintaining accurate maintenance records.
  • Perform field walkdowns, equipment inspections, and maintenance verification activities.
  • Collaborate with Facilities, Engineering, Manufacturing, Validation, and Quality teams to resolve equipment and facility-related issues.
  • Ensure maintenance activities comply with cGMP requirements, client procedures, and regulatory expectations.
  • Support facility improvements, equipment reliability initiatives, and continuous improvement efforts.
  • Communicate project updates, maintenance status, and technical findings to client stakeholders.

Skills

Facilities Engineering
Maintenance Planning
Vendor Coordination
CMMS (SAP PM)
cGMP Knowledge

Tools

SAP PM

Job description

Pioneer GMP Consulting is seeking a Facilities Engineer to support pharmaceutical and biotech manufacturing operations in the Cambridge/Boston area. The role is hands-on, combining field execution with GMP documentation responsibilities, including maintenance planning, calibration, and vendor coordination.

You will work embedded within client operations while collaborating with Facilities, Engineering, Manufacturing, Validation, and Quality teams to ensure cGMP compliance and reliable equipment

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