Job Title: Senior Maintenance Director
A highly skilled maintenance professional is sought after to lead our engineering team. As a seasoned leader, you will be responsible for providing technical expertise, strategic planning, and regulatory compliance to develop and manage capital improvement plans. Your goal will be to ensure that site infrastructure and facilities meet the highest standards of safety, quality, and efficiency.
* 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.
* Partner with Quality, EHS and Regulatory teams to ensure product safety and compliance
This position requires a strong understanding of sterile drug manufacture and cGMP requirements. You should have experience with aseptic process control strategies, proven ability to plan, design, and manage significant capital expansion projects, and knowledge of process control techniques, maintenance procedures, and safe work practices.
Key Qualifications:
* 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.
* Minimum ten years of plant engineering leadership experience in the pharmaceutical industry with a strong understanding of sterile drug manufacture and cGMP requirements