Director of Maintenance
We are seeking a highly experienced and skilled Director of Maintenance to join our team.
The ideal candidate will have a proven track record of providing technical expertise, strategic planning, and regulatory compliance in the development and management of capital improvement plans.
* Develop and manage capital improvement plans, including design, installation, and upgrading of equipment, systems, and facilities.
* 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.
* Oversight of process development, technology transfer, and automation initiatives to enhance manufacturing efficiency.
The successful candidate will have experience in sterile manufacturing and a strong understanding of regulatory requirements, including HPRA, FDA, GMP, cGMP, ISO, and other global regulatory standards.
Key Responsibilities:
* Ensure compliance with regulatory requirements.
* 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.
Requirements:
* Bachelor's or Master's in Engineering (Mechanical, Chemical, Biomedical, Industrial, or related field).
* PMP, Six Sigma Black Belt, Lean Manufacturing certified preferred.
* Strong understanding of Annex I, US, and EMA GMP regulations.
* Aseptic Process Expertise, proven experience in contamination control strategies.
* Minimum ten years of plant engineering leadership experience in the pharmaceutical industry.