Job Overview
A Director of Maintenance is a senior leadership role responsible for providing technical expertise and strategic planning to develop and manage capital improvement plans. As Director of Maintenance, you will oversee the operation, monitoring, and maintenance of pharmaceutical manufacturing equipment and facilities.
Key Responsibilities:
* Provide technical 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 regulatory standards, including HPRA, FDA, GMP, cGMP, ISO, and other global regulations.
* 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.
* Drive sustainability initiatives, reducing waste and improving energy efficiency in operations.
Requirements:
* Bachelor's or Master's degree in Engineering (Mechanical, Chemical, Biomedical, Industrial, or related field).
* PMP, Six Sigma Black Belt, Lean Manufacturing certification 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.