Manager - Engineering (MDI Facility)

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