Lead Maintenance Engineer
A highly skilled Lead Maintenance Engineer is required to oversee the development and implementation of maintenance strategies across multiple sites. The ideal candidate will have a strong understanding of sterile manufacturing processes and experience in regulatory compliance, particularly with HPRA, FDA, GMP, cGMP, ISO, and other global standards.
About the Role
* 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.
Key Responsibilities:
* Oversee process development, technology transfer, and automation initiatives to enhance manufacturing efficiency.
* Ensure compliance with regulatory requirements through validation and qualification protocols (IQ, OQ, PQ).
* Collaborate with Quality, EHS, and Regulatory teams to maintain product safety and compliance.
* 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).
* 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.