Project Engineer – MDI (Metered Dose Inhaler)
Job Title: Project Engineer – MDI (Metered Dose
Inhaler)
Job Location: Ireland
Qualification:
Diploma / Bachelor’s Degree in Mechanical Engineering
Experience:
6–10 years of relevant experience in pharmaceutical projects, preferably in MDI
facilities
Job Description:
We are seeking an experienced Project Engineer with strong exposure to
MDI projects in the pharmaceutical industry. The candidate will be responsible
for execution, coordination, and management of engineering activities related
to MDI manufacturing facilities.
Key Responsibilities:
- Lead and
execute MDI project activities from concept to commissioning
- Coordinate
with cross-functional teams including Production, QA, QC, and EHS
- Review and
finalize engineering designs, layouts, and technical specifications
- Manage
installation, testing, and commissioning of MDI equipment and utilities
- Ensure
compliance with GMP, regulatory standards, and safety guidelines
- Handle vendor
management, technical discussions, and site coordination
- Monitor
project timelines, budgets, and resource allocation
- Prepare and
review qualification documents (DQ, IQ, OQ, PQ)
- Support
preparation of SOPs, protocols, and validation documentation
- Troubleshoot
engineering issues during execution and operation phases
Requirements
Key Skills:
- Strong
knowledge of MDI systems and equipment (filling, crimping, leak testing,
etc.)
- Understanding
of cleanroom design and HVAC systems
- Familiarity
with GMP, FDA, and regulatory requirements
- Project
planning and execution skills
- Vendor
coordination and stakeholder management
- Problem-solving
and decision-making abilities
Preferred Experience:
- Experience in
greenfield or brownfield MDI projects
- Exposure to
utilities like HVAC, compressed air, nitrogen, and chilled water systems
- Hands-on
experience in qualification and validation activities