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
