Job Title: Manager – Engineering (MDI Facility)
Job Location:
Ireland
Qualification:
Diploma / Bachelor's Degree in Mechanical Engineering
Experience:
6–10 years of relevant experience in pharmaceutical engineering, with hands-on exposure to MDI facilities
Job Summary:
The Manager – Engineering will be responsible for leading the engineering function of the MDI facility, ensuring smooth operation, maintenance, compliance, and continuous improvement of all engineering systems, utilities, and equipment.
Key Responsibilities
Ensure uptime and reliability of MDI production equipment (filling, crimping, leak testing, etc.)
Oversee preventive and breakdown maintenance of plant machinery and utilities
Manage HVAC systems, cleanroom environments, and critical utilities (compressed air, nitrogen, chilled water, etc.)
Ensure compliance with GMP, regulatory requirements, and EHS standards
Lead qualification and validation activities (IQ, OQ, PQ) for equipment and utilities
Review and approve SOPs, engineering documents, and maintenance procedures
Drive continuous improvement initiatives for cost, efficiency, and energy optimization
Manage engineering projects including upgrades, expansions, and modifications
Coordinate with cross-functional teams (Production, QA, QC, EHS) for smooth plant operations
Handle vendor management, AMC contracts, and service providers
Ensure proper documentation, audit readiness, and regulatory inspections
Requirements
Key Skills:
Strong knowledge of MDI systems and pharmaceutical equipment
Expertise in utilities, HVAC, and cleanroom operations
Sound understanding of GMP, FDA, and regulatory compliance
Leadership and team management skills
Project management and problem-solving abilities
Vendor and stakeholder management
Preferred Experience
Experience in leading engineering for MDI or sterile/critical manufacturing facilities
Exposure to greenfield/brownfield projects
Experience in regulatory audits and inspections
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