Sr. Facilities Engineer
Syner-G BioPharma GroupAbout the role
COMPANY DESCRIPTION:
A career here is life-enhancing.
At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video here.
Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner.
Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation.
At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.
For more information, visit www.Synergbiopharma.com
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.
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