Project Engineer Metered Dose Inhaler

Job Description

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

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