Manager - Engineering (MDI Facility)

Tipperary, Ireland

• Industry Pharma/Biotech/Clinical Research
• Country Ireland

Job Description

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-onexposure to MDI facilities

Job Summary:

The Manager - Engineering will be responsible for leading theengineering function of the MDI facility, ensuring smooth operation,maintenance, compliance, and continuous improvement of all engineering systems,utilities, and equipment.

Key Responsibilities:

• Ensure uptimeand reliability of MDI production equipment (filling, crimping, leaktesting, etc.)
  
• Overseepreventive and breakdown maintenance of plant machinery and utilities
  
• Manage HVACsystems, cleanroom environments, and critical utilities (compressed air,nitrogen, chilled water, etc.)
  
• Ensurecompliance with GMP, regulatory requirements, and EHS standards
  
• Leadqualification and validation activities (IQ, OQ, PQ) for equipment andutilities
  
• Review andapprove SOPs, engineering documents, and maintenance procedures
  
• Drivecontinuous improvement initiatives for cost, efficiency, and energyoptimization
  
• Manageengineering projects including upgrades, expansions, and modifications
  
• Coordinatewith cross-functional teams (Production, QA, QC, EHS) for smooth plantoperations
  
• Handle vendormanagement, AMC contracts, and service providers
  
• Ensure properdocumentation, audit readiness, and regulatory inspections
  

Requirements

Key Skills:

• Strongknowledge of MDI systems and pharmaceutical equipment
  
• Expertise inutilities, HVAC, and cleanroom operations
  
• Soundunderstanding of GMP, FDA, and regulatory compliance
  
• Leadershipand team management skills
  
• Projectmanagement and problem-solving abilities
  
• Vendor andstakeholder management
  

Preferred Experience:

• Experience inleading engineering for MDI or sterile/critical manufacturing facilities
  
• Exposure togreenfield/brownfield projects
  
• Experience inregulatory audits and inspections