Maintenance Program Lead

About the Role

We are seeking a seasoned Maintenance Program Lead to spearhead the development and implementation of maintenance and reliability strategies for pharmaceutical equipment and systems at our client's site in Ringskiddy, County Cork. This role involves facilitating the seamless transition of assets from project delivery, commissioning, qualification, and validation phases (CQV) through to sustained operational status.

Key Responsibilities

• Formulate maintenance strategies tailored to GMP-compliant equipment, process systems, utilities, and facility assets.
• Conduct equipment criticality analyses and develop preventive maintenance (PM) programs accordingly.
• Create detailed maintenance job plans, define task lists, set maintenance frequencies, and establish effective calibration protocols.
• Develop and maintain accurate asset hierarchies, master data, and maintenance plans within the site’s Computerized Maintenance Management System (CMMS).
• Collaborate intimately with Engineering, CQV, Operations, and Maintenance teams during commissioning, qualification, startup, and the handover process.
• Assist in equipment inspections, system turnovers, and ensure operational readiness activities are completed efficiently.
• Guarantee all maintenance documentation and programs comply with GMP, quality assurance, and regulatory standards.

Experience and Qualifications

• Demonstrated experience in pharmaceutical, biotechnology, or other regulated manufacturing industries.
• Proven track record in maintenance program development, reliability engineering, operational readiness, or asset management.
• Familiarity with major CMMS platforms such as SAP PM, Maximo, Blue Mountain, or Infor EAM.
• In-depth knowledge of GMP-related process equipment, utilities, clean utilities, HVAC systems, and instrumentation.
• Experience supporting capital projects, CQV processes, startup phases, and system handovers is strongly preferred.
• Possession of an engineering or technical degree or equivalent experience in the industry.