Director of Maintenance
We are seeking a highly experienced Director of Maintenance to join our client's team in Galway, West of Ireland.
Key Responsibilities:
* Provide strategic direction and mentorship to the maintenance engineering team.
* Develop and implement an 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.
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.
* 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.