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Manager – Engineering (MDI Facility)

Job Description - 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







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