Project Engineer NPI

EPM Scientific; Cork; On-site; EUR 85,000 - 110,000; Full time

Job summary

EPM Scientific are currently supporting a Medical Device client in Southern Ireland to hire a Sr. Project Engineer on an 18-24 month contract. This full-time role is on-site in Ireland, starting in September.

You will drive process development, optimization, and qualification activities, own machine qualifications from design through validation, and manage capital equipment introductions. GMP and quality adherence are essential throughout the project lifecycle.

Qualifications

• Engineering mindset with experience in IQ/OQ/PQ and Validation.
• Experience in PFMEA, Process Validation, and capital equipment qualification.
• Strong problem-solving skills and structured methodologies.
• Experience supporting new product introductions and process introductions.

Responsibilities

• Drive process development, optimization, and cost reduction initiatives across business units.
• Take full ownership of machine qualifications—from design through to Process Validation.
• Apply structured problem-solving methodologies to identify root causes and implement solutions.
• Support new product and process introductions.
• Project manage the introduction of new capital equipment, including qualification and validation activities.
• Evaluate and optimize process layouts to maximise floor space and flow while upholding quality.

Skills

PFMEA

Machine Qualifications

New Product Introductions

New Process Introduction

Process Improvement

Continuous Improvement

Validation

MSA

Job description

EPM Scientific are currently supporting a Medical Device client in Southern Ireland to hire a Sr. Project Engineer on an NPI project, working on a long term (18-24 month) contract. Full time on site, starting in September.

Job details:

• Drive process development, optimization, and cost reduction initiatives across the business units.
• Take full ownership of machine qualifications - from design through to Process Validation.
• Apply structured problem-solving methodologies to identify root causes and implement effective solutions.
• Support new product and process introductions
• Project manage the introduction of new capital equipment, including associated qualification and validation activities.
• Evaluate and optimize process layouts to support new integrations, maximise floor space utilisation, and achieve optimal process flow while upholding product and process quality standards.
• Participate in the selection of components and equipment based on specifications, reliability, and regulatory requirements; collaborate with quality engineers to develop component-specific testing and inspection protocols.
• Contribute to the creation of PFMEA, Control Plans, SOPs, and PPAP documentation for product transfers and launches.
• Conduct Measurement System Analysis (MSA) studies for new products and processes.
• Deliver training and support to manufacturing team members.
• Ensure strict adherence to GMP, safety, and quality procedures.
• Review and approve validation documentation.
• Perform other duties as assigned.

Desired Skills and Experience

Engineering, IQ, OQ, PQ, Validation, Continuous Improvement, Process Improvement, PFMEA, Machine Qualifications, New Product Introductions, New Process Introduction