- Collaboration with other departments and out-sourced partners to ensure the successful delivery of the Facility and Utility Support function in the safest, most time efficient and cost-effective manner.
- Maintain Facility and Utility Support services in the context of retaining a permanent inspection readiness state for the site.
- Support continuous improvement by active participation in projects, system failure studies and incident investigations using recognised methodologies such as 8SPS, RCA etc.
- Support the development and execution of Change Control related to the Engineering function.
- Participate in and contribute to Lean measures such as Gemba and Kaizen events.
- Comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
- Accountable for compliance via documentation completion, risk assessments, closing out corrective actions, participate in audits and inspections and proactively highlighting any issues around compliance.
- Escalate issues in a timely manner to relevant onsite stakeholders and support the resolution of any such issues.
- Development of new and review and update of existing SOPs.
- Support site Reliability and Calibration improvement programs.
- Collaborate closely with cross functional teams to ensure project activity is supported through inspection and safety walks.
- Work collaboratively to drive a safe and compliant culture onsite.
- Collaborate with multiple partners (e.g., Operations, Supply Chain, Warehouse, Quality, Labs, Third Parties, Vendors etc).
- Drafting presentations and reporting out on progress on initiatives to stakeholders as required.
- Managing vendors for work on site ensuring compliance with safety and permitting requirements for all on site activities.
- Responding to safety events, collecting information and coordinating investigations and remediation actions.
- Responding to building fabric issues, collecting information to support investigations and coordinating closure of remediation actions.
- Supervision of temporary building utilisation and responding to issues as they arise.
- Overseeing building utilisation and conducting periodic occupancy checks.
- May be required to perform other duties as assigned.
- Bachelor's Degree or higher preferred; ideally in an Engineering, Science or other technical discipline.
- Minimum 3 years' experience in a comparable role typically gained operating as an independent contributor adding considerable value to the business.
- Lean Six Sigma Methodology experience desired with Green Belt preferred.
- Demonstrated ability to deliver on objectives with limited oversight.
- Experience within Facilities and Utilities support areas in a GMP manufacturing environment and have a proven track record in identifying and delivering improvement projects.
- Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
- Excellent report, standards, policy writing skills required.
- Proficiency in Microsoft Office suite and job-related computer applications required.
- Proven record of management of change in a commercial site.
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Facilities Engineer - Ireland - Tandem Project Management Ltd.
Description
Summary:
A Facilities Engineer is required for a biopharmaceutical company in Carlow. The successful candidate will be responsible for planning, implementing and maintaining the infrastructure and equipment of buildings and facility related equipment at the site. The ideal person will have prior relevant facility engineering experience preferably gained in a GMP manufacturing setting with experience providing support to the facility and utility support functions.
Responsibilities:
Qualifications & Experience: