Factilities Engineer

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

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

About the Opportunity

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.

What You’ll Do

• 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

Required Qualifications

• Five to eight years of Facilities Engineering, Facilities Maintenance, Metrology, Calibration, Maintenance and Reliability, or related experience in GMP pharmaceutical or biotechnology manufacturing
• Significant hands‑on experience performing or overseeing calibrations within a regulated manufacturing environment
• Experience reviewing calibration certificates, tolerances, as‑found and as‑left data, out‑of‑tolerance results, and supporting documentation
• Experience performing or overseeing preventive maintenance, corrective maintenance, troubleshooting, and equipment‑support activities
• Experience coordinating and supervising calibration, maintenance, or facility‑service vendors
• 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
• Experience supporting GMP facilities, utilities, instrumentation, and manufacturing equipment
• Experience documenting or supporting investigations involving calibration failures, equipment issues, or maintenance events
• Ability to perform field walkdowns and verify completed calibration and maintenance activities
• Ability to work extensively in manufacturing, mechanical, and utility areas
• Strong organizational, communication, technical‑writing, and problem‑solving skills
• Ability to manage multiple concurrent work orders, vendors, schedules, and documentation requirements
• Ability to work independently within a client‑facing consulting environment
• Ability to work onsite in the Cambridge/Boston area
• Bachelor’s degree in engineering or a related technical discipline, or equivalent relevant industry experience

What Will Set You Apart

• Experience supporting high‑volume GMP calibration programs
• Experience with critical GMP instrumentation, including pressure, temperature, flow, level, analytical, environmental‑monitoring, or control instruments
• Experience supporting HVAC, clean utilities, process gases, water systems, or other critical facility systems
• Strong working knowledge of SAP Plant Maintenance master data, maintenance plans, task lists, notifications, and equipment history
• Experience investigating out‑of‑tolerance conditions and assessing potential product, process, equipment, or validated‑state impact
• Experience managing outsourced calibration or maintenance programs
• Experience supporting facility startup, operational readiness, turnover, or transition from project execution into ongoing operations
• Experience working alongside construction, commissioning, qualification, or validation teams
• Experience supporting deviations, CAPAs, change controls, audit readiness, or maintenance remediation
• Prior consulting or staff‑augmentation experience
• Ability to enter an active program and become productive with minimal ramp‑up time
• Local availability within commuting distance of Cambridge or Boston

What Success Looks Like

You will be successful in this role when:

• Calibration and maintenance activities are executed safely, correctly, and on schedule
• Vendors follow client procedures and produce complete, acceptable documentation
• SAP work orders accurately reflect the work performed and are closed promptly
• Calibration records and maintenance documentation are complete, traceable, and inspection‑ready
• Out‑of‑tolerance conditions and equipment concerns are identified, assessed, and escalated appropriately
• Equipment is not returned to service until required work and documentation are complete
• Risks, constraints, documentation gaps, and potential delays are communicated early
• Client stakeholders view you as dependable, knowledgeable, responsive, and solutions‑oriented
• You become productive quickly without requiring extensive day‑to‑day direction

Know Before You Apply

• This position requires onsite work in the Cambridge/Boston area.
• Remote and hybrid arrangements are not expected for the initial engagement.
• You will spend significant time in manufacturing, mechanical, and utility areas.
• Calibration is a substantial component of the role.
• This is a hands‑on execution and vendor‑supervision position—not a commissioning‑management or remote‑oversight role.
• The initial engagement is expected to last a minimum of 12–18 months.
• Maintenance schedules, shutdowns, calibration requirements, or equipment issues may occasionally require schedule flexibility.
• Future Pioneer assignments may involve different clients, locations, schedules, responsibilities, work arrangements, or travel requirements.
• Please disclose any scheduling, location, travel, or availability limitations during the recruiting process.

Compensation and Benefits

Compensation Range: Compensation is determined based on experience, technical expertise, engagement requirements, and other job‑related factors.

• Medical insurance, with Pioneer currently contributing 50% of employee premiums
• Vision insurance
• $100,000 basic life insurance
• Direct access to Pioneer leadership
• Opportunities to support high‑impact client engagements

Benefits are subject to eligibility requirements and applicable plan documents. Benefit offerings may change over time.

Equal Opportunity Employer

Pioneer GMP Consulting is an Equal Opportunity Employer. We consider qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected category under applicable federal, state, or local law.