GM

Job Description : GM – Engineering (Greenfield Projects) | Sterile Pharma (SVP) IRELAND ???? Experience: 25+ Years ? Minimum 4–5 complete Greenfield Sterile SVP Projects executed from concept to commercial production. ? Hands-on experience in Regulatory Audits (USFDA, EU GMP, MHRA, WHO-GMP, PIC/S, etc.). ? Brownfield Project experience alone will not be considered. ? Plant Engineering / Maintenance-only profiles are not eligible. Key Responsibilities: Lead complete Greenfield Sterile SVP Plant projects from planning, design, execution, commissioning, qualification, validation, and commercial launch. Manage engineering activities for HVAC, Clean Utilities, Water Systems (PW/WFI), Steam, Compressed Air, Electrical, Automation, and Building Services. Coordinate facility layout, equipment selection, procurement, installation, FAT, SAT, IQ, OQ, and PQ. Ensure compliance with cGMP, USFDA, EU GMP, MHRA, WHO-GMP, Schedule M, ISO, and other global regulatory requirements. Lead preparation and readiness for domestic and international regulatory inspections. Drive project planning, budgeting, vendor management, risk assessment, and timeline adherence. Coordinate with Production, QA, QC, Validation, EHS, Procurement, and Project teams for seamless execution. Implement engineering documentation, SOPs, change control, CAPA, deviation management, and qualification protocols. Ensure utility reliability, energy optimization, preventive maintenance strategy, and engineering excellence. Lead cross-functional teams while maintaining quality, safety, compliance, and project milestones.

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