Manager – Engineering (MDI Facility)
Test Triangle · Tipperary, The Municipal District of Cahir — Cashel, Ireland
IT Services and IT Consulting · 51-200 employees
About the role
The Manager will lead the engineering function at the MDI facility, overseeing the maintenance, reliability, and compliance of production equipment and utilities. They will also manage engineering projects, drive continuous improvement initiatives, and ensure audit readiness through effective documentation and cross-functional coordination.
What they look for
Requirements
Candidates must hold a Diploma or Bachelor’s degree in Mechanical Engineering with 6–10 years of relevant experience in pharmaceutical engineering. Expertise in MDI systems, HVAC, cleanroom operations, and regulatory standards like GMP and FDA is essential.
Full 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-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
