Facilities Engineer
Summary:
Responsible for supporting operational readiness and ongoing reliability of facility and utility systems within a GMP-regulated environment. This role focuses on system design, documentation, maintenance, and continuous improvement to ensure safe, compliant, and efficient delivery of facility services to production.
Responsibilities:
• Support the Utilities Manager with operational readiness activities for the Facility department, including IPA and PG Tank Farm systems.
• Prepare, review, and maintain technical and operational documentation to ensure sustainable utility performance and GMP compliance.
• Design and modify components, systems, and processes; develop detailed design specifications.
• Oversee contractor safety through permit-to-work systems and review of risk assessments and method statements.
• Maintain and improve CMMS procedures, focusing on system readiness, resource planning, and maintenance execution.
• Conduct system impact, criticality, and risk assessments; generate and review URS, FS, and DS documentation.
• Coordinate and execute FAT, SAT, and IQ activities for facilities equipment.
• Manage small to medium engineering projects, ensuring alignment with project scope, schedule, and GMP standards.
• Develop and deliver technical training for technicians and operators.
• Participate in investigations and root cause analysis for equipment, utility, and control system issues.
• Drive continuous improvement in safety, energy efficiency, and waste reduction using lean principles.
• Ensure vendor documentation and services meet quality and compliance standards.
• Support regulatory audits and EHS assessments, evaluating environmental and safety impacts of new systems or materials.
Requirements:
• Bachelor’s degree in Chemical, Mechanical, or Process Engineering (or related field).
• Minimum 5 years’ experience in Engineering within GMP, Biotech, or Medical Device environments.
• Strong understanding of CMMS and asset management strategies.
• Proven knowledge of utility systems, automation platforms (SCADA, Historians), and validation documentation.
• Excellent communication, interpersonal, and coordination skills.
• Experience working on ATEX-rated sites is an advantage.
• Demonstrated ability to lead safety, quality, and continuous improvement initiatives.
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