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 experience with Sterile Manufacturing Experience.
Role of this position
* Provide 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 goals
* Oversee process development, technology transfer, and automation initiatives to enhance manufacturing efficiency
* Ensure 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 manufacturing
* Partner with Quality, EHS and Regulatory teams to ensure product safety and compliance
* Collaborate with Operational Excellence teams to optimize HVAC, cleanrooms, water treatment, and aseptic processing systems to maintain sterile environments
* Drive sustainability initiatives, reducing waste and improving energy efficiency in operations
* Lead multi-disciplinary engineering teams across multiple sites and global operations
* Develop talent through mentorship, training programs, and succession planning
* Oversee engineering budgets, ensuring cost control and ROI on capital expenditures
* Identify and mitigate risks in production, supply chain, and facility operations
* Develop, 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 REQUIREMENTS
* Bachelor's or Master’s in Engineering (Mechanical, Chemical, Biomedical, Industrial, or related field)
* PMP, Six Sigma Black Belt, Lean Manufacturing certified preferred
* Regulatory 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 requirements
* Strong technical understanding of the operation, monitoring and maintenance of pharmaceutical manufacturing equipment and facilities. This includes environmental control equipment and other utilities
* Demonstrated ability to plan, design and manage significant capital expansion projects
* Knowledge of process control techniques, maintenance procedures and safe work practices along with a working knowledge of engineering codes and standards
* Experience with regulatory & documentation requirements that relate to facilities upgrades, qualifications and equipment purchases, installations, qualifications and validations
* Strong problem solving and critical thinking skills
* Excellent communication, writing, presentation and data organisation skills
* Demonstrated interpersonal and leadership qualities
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