Senior Facilities Engineer - excellent opportunity in Medical Devices manufacturing in Limerick. Candidates with 5 yrs experience of Facilities and Maintenance Engineering in a GMP please apply.
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Role:
Description:
Responsibilities
* Support the Utilities Manager in the Ops readiness tasks for the Facility department responsibilities on the IPA and PG Tank Farm.
* Ongoing preparation and review of technical and operational documentation and procedures applicable to ensuring sustainable delivery of Utility and facility services to the product production.
* Creates/modified designs for intermediate problems.
* Designs/modifies complex components/processes.
* writes detailed design specifications.
* Safety management of maintenance contractors – Utilise the permit to work systems. Review RA MS documents.
* Ongoing review and updating of CMMS procedures with a focus on system readiness and resource availability.
* Grasps complexities and sees relationships amongst data
* Determines consequences and alternatives; makes recommendations
* Support resource estimates and coordination needed (materials, budget, time and people) to accomplish assigned individual tasks.
* Anticipates future directions. Benchmarks internally and externally. Recognizes changes in the environment and present resources as indicators of future problems and opportunities
* Plan/conduct small- to medium-size assigned projects within FM engineering requiring conventional types of plans, investigations, and/or equipment
* Coordinates and monitor activities associated with projects under the relevant scope of the role
* Liaise with the various stakeholders on the Project team and the overall project to ensure clear communication between all parties
* Review and approve project documentation, ensuring technical accuracy and adherence to GMP standards.
* Supporting the generation of key deliverables (in a phase appropriate compliance manner) including system impact assessments, criticality assessments, risk assessments, user requirements specifications, function specifications, design specification
* Prepare and execute FAT / SAT and IQ protocols for facilities equipment.
* Develop training materials and deliver training to technicians / operators.
* Responsible for compliance with applicable policies and procedures
* Encourage compliance with all company Safety, Environmental and Quality systems
* Assist in investigations and root cause analysis of process equipment, utility systems and control system anomalies, as well as safety incidents.
* Ensure that value engineering, constructability reviews and similar processes are effectively utilized to minimize capital expenditures and maximize functional value.
* Initiate, support and execute continuous improvement activities in safety, energy efficiency, waste elimination across functional areas (production, utilities, logistics, maintenance etc) using lean manufacturing principles
* Confirm vendor documentation and executions are compliant prior to service delivery
* Support internal and external regulatory audits preparations and follow on requirements
Education & Experience
• Bachelor's degree in chemical engineering or related program with the following years in relevant experience:
• 5+ years' experience of working within Engineering in a regulated GMP/Biotech/Med Device environment.
• Understanding of CMMS/Asset management strategies and applications
• Excellent interpersonal and communication skills with leadership abilities.
• Experience on ATEX rated sites is a distinct advantage.
• Familiarity with Automated equipment and Automation systems plus supporting systems – SCADA / Historians