POSITION OVERVIEW:
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.

WORK LOCATION:
Travel to client sites may be required up to 100%, depending on project demands and client expectations.

KEY RESPONSIBILITIES:
(This list is not exhaustive and may be modified as needed.)

• 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.

QUALIFICATIONS AND REQUIREMENTS:

Education

• Bachelor's degree in Engineering (Mechanical, Chemical, Electrical preferred) or a related technical field.

Experience

• 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.
• CAPEX project experience is preferred.

Knowledge, Skills, and Abilities

• 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.
• Familiarity with ISPE guidance and ASTM E2500 is preferred.
• 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.

ESSENTIAL FUNCTIONS:

Physical Demands:

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.

TOTAL REWARDS PROGRAM:

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work "almost anywhere." However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.