A Director of Maintenance is required by CareerWise Recruitment for our Galway, West of Ireland based client. As Director of Maintenance, you will be responsible for providing technical expertise, strategic planning and regulatory compliance to develop and manage capital improvement plans, including the Design, Installation, and Upgrading of Equipment, Systems, and Facilities to ensure that site infrastructure and facilities meet the highest standards of safety, quality, and efficiency. With a proven track record of strong people leadership and development, you will be responsible for building and nurturing high-performing teams, fostering a culture of collaboration, accountability, and continuous improvement. The successful candidate will have Sterile Manufacturing Experience, as well asAseptic Process Expertise.Role of this positionProvide strategic direction, mentorship, and performance management for the maintenance engineering team.Develop and implement a clear organizational structure for the engineering team to ensure smooth operations and clear responsibilities.Define and implement engineering strategies aligned with business goalsOversee process development, technology transfer, and automation initiatives to enhance manufacturing efficiencyEnsure compliance with HPRA, FDA, GMP, cGMP, ISO, and other global regulatory standards.Oversee the development and maintenance validation and qualification protocols (IQ, OQ, PQ) for pharmaceutical manufacturingPartner with Quality, EHS and Regulatory teams to ensure product safety and complianceCollaborate with Operational Excellence teams to optimize HVAC, cleanrooms, water treatment, and aseptic processing systems to maintain sterile environmentsDrive sustainability initiatives, reducing waste and improving energy efficiency in operationsLead multi-disciplinary engineering teams across multiple sites and global operationsDevelop talent through mentorship, training programs, and succession planningOversee engineering budgets, ensuring cost control and ROI on capital expendituresIdentify and mitigate risks in production, supply chain, and facility operationsDevelop, Implement, and promote a Reliability Centered Maintenance (RCM) strategy using Failure Mode Effects and Criticality Analysis (FMECA/FMEA) assessments in conjunction with department management, the Engineering dept reliability engineer and the Production department utilizing tools such as Trend’s analysis & Control charts & Data review.JOB REQUIREMENTSBachelor's or Master’s in Engineering (Mechanical, Chemical, Biomedical, Industrial, or related field)PMP, Six Sigma Black Belt, Lean Manufacturing certified preferredRegulatory Knowledge: Strong understanding of Annex I, US, and EMA GMP regulations, with practical experience in regulatory audits.Aseptic Process Expertise, proven experience in contamination control strategies, including cleaning and disinfection validation.Minimum ten years of plant engineering leadership experience in the pharmaceutical industry with a strong understanding of sterile drug manufacture and cGMP requirementsStrong technical understanding of the operation, monitoring and maintenance of pharmaceutical manufacturing equipment and facilities. This includes environmental control equipment and other utilitiesDemonstrated ability to plan, design and manage significant capital expansion projectsKnowledge of process control techniques, maintenance procedures and safe work practices along with a working knowledge of engineering codes and standardsExperience with regulatory & documentation requirements that relate to facilities upgrades, qualifications and equipment purchases, installations, qualifications and validationsStrong problem solving and critical thinking skillsExcellent communication, writing, presentation and data organisation skillsDemonstrated interpersonal and leadership qualities
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