NPI Engineer

EPM Scientific; Cork; On-site; EUR 42,000 - 59,000; Full time

Job summary

EPM Scientific is partnering with a leading MedTech client in Cork to recruit 2 Project Engineers for an initial 18‑month, on‑site contract, focusing on Cleanroom NPI activities. Start dates are ASAP and roles are paid on a daily rate.

The roles require driving process development, machine qualification ownership, and the creation of PFMEA, SOPs, and PPAP documentation. You will ensure GMP, safety, and quality standards on the factory floor while supporting capital equipment introductions.

Qualifications

• 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 qualification and validation activities.
• Evaluate and optimize process layouts to support new integrations, maximise floor space utilisation, and uphold quality standards.
• Collaborate with quality engineers to develop component-specific testing and inspection protocols.
• Contribute to PFMEA, Control Plans, SOPs, and PPAP documentation for transfers and launches.
• Conduct Measurement System Analysis (MSA) studies for new products and processes.
• Deliver training and support to manufacturing team members.
• Adhere to GMP, safety, and quality procedures.
• Review and approve validation documentation.

Responsibilities

• Own process development and optimization efforts on site.
• Lead machine qualification activities from design through validation.
• Perform MSA studies and contribute to QA documentation quality.
• Support introductions of new products and processes and ensure GMP compliance.
• Provide training and guidance to manufacturing staff on new processes.

Skills

Process Engineering

Process Optimization

PFMEA

Validation

SOPs

PPAP

Qualifications

Cleanroom

Cleanline

NPI

GMP

Job description

EPM Scientific are currently supporting a leading MedTech client to recruit 2 Project Engineers to join their Cork site on initial 18 month contracts, supporting Cleanroom NPI activities. Both roles are ASAP starts, primarily on site, and paid on a daily rate. Job description:

• 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.

Desired Skills and Experience Process Engineering, Process Optimization, PFMEAs, Validation, SOPs, PPAP, Qualifications, Cleanroom, Cleanline, NPI, GMP