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Facilities Engineer

Pioneer GMP Consulting

We’re seeking a Facilities Engineer to join our team at Pioneer GMP Consulting and support clients across pharmaceutical and biotech manufacturing environments in the Cambridge/Boston area. As part of our consulting team, you’ll operate as a trusted partner—embedded within client operations while remaining closely connected to and supported by Pioneer’s internal network of industry experts. You’ll play a key role in helping clients bring critical systems and facilities online safely, efficiently, and in compliance with GMP and regulatory expectations. In this role, you’ll support commissioning, qualification, and validation activities across a wide range of GMP systems, equipment, utilities, and manufacturing environments. Your work may span facility startups, capital projects, equipment qualification, operational readiness initiatives, and ongoing manufacturing support. Success in this role requires strong technical expertise, attention to detail, problem‑solving ability, and the confidence to collaborate with stakeholders across Engineering, Manufacturing, Quality, and Validation teams. This is a long‑term consulting opportunity—not a single project assignment. You’ll have the opportunity to contribute across multiple client engagements and gain exposure to diverse technologies, manufacturing processes, and facility types throughout the life sciences industry. What You’ll Do Support day‑to‑day Facilities Engineering activities within GMP‑regulated manufacturing environments. Perform and oversee field execution of 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. Qualifications 5–8 years of experience supporting Facilities Engineering, Facilities Maintenance, or Maintenance & Reliability within GMP‑regulated pharmaceutical or biotechnology manufacturing environments. Hands‑on experience performing or overseeing calibration, preventive maintenance, corrective maintenance, and equipment support activities. Experience coordinating and supervising maintenance contractors or third‑party service providers. Strong knowledge of GMP documentation practices and maintenance record management. Experience using SAP Plant Maintenance (PM) or similar computerized maintenance management systems (CMMS) to create, manage, and close work orders. Strong understanding of cGMP requirements and regulated manufacturing environments. Experience supporting GMP utilities, facility systems, and manufacturing equipment. Comfortable working extensively in manufacturing and utility areas while supporting field execution activities. Strong communication, organization, and problem‑solving skills. Ability to work independently in a client‑facing consulting environment while managing multiple priorities. Willingness to work onsite in the Cambridge/Boston area and travel as needed to support future client engagements. What Will Set You Apart Prior consulting experience supporting regulated pharmaceutical or biotechnology manufacturing environments. Strong consultative approach with the ability to partner effectively across Facilities, Engineering, Manufacturing, Quality, and leadership teams while delivering practical, compliance‑focused solutions. Experience supporting GMP facilities, utilities, and manufacturing operations within commercial manufacturing environments. Experience managing vendor relationships and coordinating outsourced maintenance or calibration services. Strong working knowledge of SAP Plant Maintenance (PM) or comparable CMMS platforms supporting GMP maintenance programs. Ability to translate technical and compliance requirements into clear, practical documentation and actionable solutions. Thrives in hands‑on, fast‑paced manufacturing environments where safety, compliance, and execution are critical. Proactively identifies equipment reliability, maintenance, and operational improvement opportunities. Builds strong relationships and represents Pioneer with professionalism, credibility, and accountability. Experience supporting FDA inspection readiness, audit support, or maintenance remediation initiatives. Competitive consulting rates commensurate with experience. Travel reimbursement and related expenses may apply depending on engagement requirements. Equal Opportunity Employer Pioneer GMP Consulting is an Equal Opportunity Employer. We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected category under applicable law. #J-18808-Ljbffr

Vacancy posted 3 days ago
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