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.