Manufacturing Validation Engineer

CREGG; Tipperary; Hybrid; EUR 55,000 - 75,000; Full time

Job summary

CREGG seeks a Manufacturing Engineer for our Clonmel site with hybrid work options. You will support daily operations, validate new equipment, implement process improvements, and lead equipment transfers between clean rooms in a highly regulated medical devices environment.

You will collaborate with engineering, QA, EHS and production teams to ensure quality, compliance and on-time production goals. 2–5 years in engineering is preferred.

Qualifications

• NFQ Level 8 in a Technical Discipline (Science, Biomedical, Mechanical, Manufacturing, etc.).
• Minimum 2–5 years’ experience at an Engineering level, ideally in Medical Device industry or other highly regulated environment.
• Automated Manufacturing equipment experience advantageous.

Responsibilities

• Introduction and validation of new equipment.
• Analyze process, product, material or equipment specs and performance requirements.
• Collaborate with cross-functional teams to resolve production/engineering issues.
• Summarize, analyze and draw conclusions from test results for technical resolution.
• Transfer and validate equipment between clean rooms.
• Continuous Improvement & Yield Analysis.
• Drive improvements in process equipment design, layout and performance.
• Engage with technicians and cross-functional teams for process success.
• Root cause analysis using Lean tools and techniques.
• Write and improve process procedures.
• Apply validation techniques and regulatory requirements.
• Promote cross-functional teamwork.
• Evaluate environmental impact of new equipment/processes/chemicals.
• Provide technical guidance to Associate Engineers and technicians.

Skills

Root cause analysis

Lean tools

Validation procedures

Education

NFQ Level 8 in a Technical Discipline

Tools

Automated Manufacturing equipment

Job description

Manufacturing Engineer – Clonmel (Hybrid)

About the role:

Our Clonmel based client are now recruiting for a Manufacturing Engineer to join their team.

An excellent Hybrid working opportunity to work with a leading medical devices company.

The successful candidate will be responsible for providing daily support of and equipment, processes, materials, in order to achieve production goals along with develop and implement manufacturing business improvement process improvement projects and processes working with Automated Equipment.

This is a Projects role involving equipment introduction, line moves, equipment validation, equipment qualification, process improvements, line upgrades.

Responsibilities:

• Responsible for the introduction and validation of new equipment
• Analyses process, product, material or equipment specifications and performance requirements.
• Work with cross-functional teams to identify and resolve production/engineering issues.
• Summarises, analyses, and draws conclusions from test results leading to effective technical resolution.
• Transfer and validation of equipment from one clean room to another.
• Continuous Improvement & Yield Analysis.
• Continually seeks to drive / improvements in process equipment design, layout and operational performance.
• Engaging with technicians, operators, and other cross-functional teams to ensure business process success.
• Root cause analysis using Lean tools and techniques.
• Writing and improving process procedures.
• Demonstrates good working knowledge and application of validation techniques and associated regulatory requirements.
• Actively promotes and participates in a cross -functional teamwork environment.
• Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
• Gives technical guidance to Associate Engineers and technicians.
• Understands and comply with all the regulations governing the quality systems.
• Ensures all direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.

Qualifications and Experience:

• NFQ Level 8 in a Technical Discipline (Science, Biomedical, Mechanical, Manufacturing, etc.)
• Minimum 2-5 years’ experience working at an Engineering level, ideally in Medical Device industry or other highly regulated environment.
• Automated Manufacturing equipment experience advantageous