Sr. Facilities Engineer

Syner-G•Waltham, MA

4h•Remote

About The Position

Syner-G is seeking a Senior Facilities Engineer with 5–10 years of experience supporting and leading commissioning, qualification, validation, and ongoing operation of GMP facility systems across laboratory, manufacturing, and utility environments. This role combines facilities engineering ownership (utilities, maintenance, infrastructure) with CQV lifecycle execution, ensuring that facility systems are designed, commissioned, qualified, maintained, and compliant with GMP and regulatory expectations. The Senior Engineer will act as a technical subject matter expert across facility systems, lead validation efforts, support lifecycle management, mentor junior staff, and collaborate cross-functionally to ensure safe, reliable, and inspection-ready operations.

Requirements

Bachelor’s degree in Engineering (Mechanical, Chemical, Electrical preferred) or a related technical field.
5–10 years of experience in CQV, validation engineering, facilities engineering, or a blended role.
Strong experience supporting GMP utilities, cleanroom environments, and facility systems.
Experience with commissioning and qualification of facility and utility systems.
Strong understanding of CQV lifecycle and validation principles.
Knowledge of GMP regulations (FDA, EMA) and data integrity requirements.
Experience with utilities and infrastructure systems in regulated environments.
Strong troubleshooting, root cause analysis, and problem-solving skills.
Ability to develop and interpret engineering and validation documentation.
Excellent communication, leadership, and collaboration skills.
Highly organized and capable of balancing project-based work with ongoing operations support.

Nice To Haves

CAPEX project experience is preferred.
Familiarity with ISPE guidance and ASTM E2500 is preferred.

Responsibilities

Lead and execute commissioning, qualification, and validation (CQV) activities for facility systems, utilities, and GMP infrastructure such as HVAC, clean utilities, process gases, and electrical systems.
Develop and approve validation lifecycle documentation including user requirements specifications (URS), design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
Support risk assessments such as FMEA and system classification (GxP vs. non-GxP).
Ensure systems are designed and maintained in alignment with GMP, ISPE guidance, and regulatory requirements.
Lead commissioning readiness, system turnover, and release to operations.
Support periodic review, requalification, and change control activities.
Oversee operation, maintenance, and reliability of critical facility systems and utilities including HVAC, chilled water, steam, WFI, compressed air, process gases, electrical systems, and building management systems (BMS/EMS).
Lead, schedule, and manage corrective maintenance and preventative maintenance programs.
Conduct system monitoring and performance trending to ensure reliability and compliance.
Perform inspections and drive continuous improvement initiatives for facility systems.
Maintain and verify engineering documentation including P&IDs, electrical one-lines, and airflow diagrams.
Lead troubleshooting and root cause investigations for utilities, GMP equipment, and infrastructure.
Support deviation investigations and CAPA development.
Respond to alarms, system failures, and emergency events with technical leadership.
Ensure all systems remain in a validated and audit-ready state.
Maintain documentation in compliance with SOPs, GMP requirements, and data integrity standards.
Support internal and external audits and regulatory inspections.
Partner with Engineering, Manufacturing, Quality, Validation, and R&D to support operations and projects.
Provide engineering support for capital projects including design review, FAT/SAT, and commissioning activities.
Ensure smooth transition from project CQV phases into steady-state facilities operations.
Serve as a technical subject matter expert and mentor junior engineers and technicians.
Manage multiple projects and priorities with minimal oversight.