Provide technical SME for various Facility and Utilities systems, ensuring compliance to all company and regulatory procedures at all times.
- Ensure that all equipment is properly operated and maintained in line with Company standards, local and EU regulations and industry best practice.
- Implementation of Facilities and Utilities projects from inception, through to completion.
- Collaborate cross-functionally with outsourced partners and other departments to successfully complete tasks.
- Work collaboratively to drive a safe and compliant culture in the facility.
- Development of site safety documentation and procedures.
- May be required to act as point of contact for new capital and expense projects impacting the facilities area.
- Identify, troubleshoot, investigate and remedy process and equipment issues and incidents, using Lean Six Sigma tools as applicable.
- Lead continuous improvement projects through the identification of CAPAs from system failure investigations and investigation reports.
- Lead complex multifunctional root cause analysis of system, process and equipment failures including, substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; oversee and implement subsequent corrective action, through the change management system.
- Development of Company standard SOPs and implementation of equipment maintenance plans, thereby ensuring all equipment is properly operated and maintained.
- Drive compliance in line with Company Global Policies, Procedures, Guidelines, and regulatory requirements.
- Execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions
- Complete reviews, approvals and close-out of technical documentation in line with site standard approval process.
- Direct and/or lead investigations re: deviations, out of tolerance conditions and unexpected results, conducting failure analysis, root cause determination and implementing corrective actions; preparation and analysis of facilities metrics reports to trend for improved operational efficiencies.
- Provide support with audit/inspection requirements to ensure department compliance/readiness.
- Participate in internal and external audits and inspections.
- Recognize and investigate opportunities for financial savings and supports opportunities for financial savings by providing resources, expertise and project work.
- May be required to perform other duties as assigned
Qualifications & Experience:
- Bachelors Degree or higher preferred; ideally in an Engineering or other Technical discipline
- 3 + years of related work experience in a GMP manufacturing environment or equivalent.
- Experience of mechanical/electrical/pneumatic processes
- Experience of working in a highly regulated environment applying regulations and compliance in all tasks undertaken
- Applicant should have previously demonstrated strong team and communication skills, flexibility, and motivation, with a strong emphasis around safety and compliance practices.
- Applicants should actively support, participate and embrace an empowered team culture.
- Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
- Report, standards, policy writing skills required.
- Proficiency in Microsoft Office and job related computer applications required.
- Lean Six Sigma Methodology experience desired.
- Ability to plan, prioritise and effectively manage time, meet deadlines and produce quality deliverables.
- Excellent verbal and written communication skills.
- Ability to identify areas for improvement either in business systems or product development.
- Demonstrated ability to be self driven with respect to implementing identified improvement initiatives.
- Excellent attention to detail.
- Starter, finisher.
- Vendor liaison.
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