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