Director of Maintenance
We are seeking a seasoned professional to lead our maintenance team. As Director of Maintenance, you will be responsible for providing technical expertise and strategic planning to develop and manage capital improvement plans.
This includes 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.
You will also 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 processes and be able to 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 regulatory standards, including HPRA, FDA, GMP, cGMP, ISO, and other global standards.
* Partner with Quality, EHS, and Regulatory teams to ensure product safety and compliance.
The ideal candidate will have a strong understanding of annex I, US, and EMA GMP regulations and have practical experience in regulatory audits.
Aseptic process expertise and proven experience in contamination control strategies, including cleaning and disinfection validation, are also required.
Bachelor's or Master's in Engineering (Mechanical, Chemical, Biomedical, Industrial, or related field) is preferred, along with PMP, Six Sigma Black Belt, Lean Manufacturing certified.
Maintenance Lead