Validation Engineer – 6-Month Contract

Sigmar Recruitment; Fermoy; On-site; EUR 80,000 - 90,000; Full time

Job summary

Sigmar Recruitment is seeking a Validation Engineer for a 6-month contract in Fermoy, Cork, within commuting distance. You will own and support validation activities across medical device manufacturing, including processes, equipment, facilities, utilities, software and computer systems.

The role reports to the Validation Quality Lead. Requirements include a QQI Level 7 degree in science or engineering, 1+ year in Quality Assurance or Regulatory Affairs, and strong problem-solving skills;

Qualifications

• A QQI Level 7 degree in Science, Electronics, Mechanical Engineering or related discipline.
• Experience working in a medical device manufacturing or pharmaceutical environment.
• At least one year in Quality Assurance or Regulatory Affairs.
• Experience validating processes, equipment, facilities, utilities, software or computer systems.
• DOE, DMAIC and statistical analysis experience.
• Proficiency in Word, PowerPoint and Excel.
• Ability to prepare SOPs, training documents and regulatory responses.
• GAMP 5 experience advantageous but not essential.

Responsibilities

• Managing assigned Process, Equipment, Facility, Utility, Software and Computer System Validation activities.
• Preparing Validation Plans, Protocols and Reports.
• Supporting resolution of issues identified during validation activities.
• Ensuring a consistent validation and qualification approach across systems and projects.
• Providing guidance on preparation and execution of validation activities.
• Maintaining the site validation system, including periodic reviews.
• Participating in change control processes relating to manufacturing processes, equipment, facilities, utilities and computer systems.
• Supporting ongoing GMP, quality and industry regulatory requirements.
• Ensuring all activities are completed accurately and within agreed timelines.

Skills

Quality Assurance

Regulatory Affairs

Statistical Analysis

DOE

DMAIC

Problem Solving

Microsoft Word

Microsoft Excel

Education

QQI Level 7 degree in Science/Engineering

Tools

GAMP 5

Job description

Validation Engineer – 6-Month Contract

About Your New Employer

• Join a regulated medical device manufacturing environment where quality, compliance and technical excellence are central to the operation.
• Work alongside experienced Quality and Validation professionals on critical manufacturing, equipment, facility, utility, software and computer system validation activities.
• Gain valuable experience supporting GMP compliance and regulatory standards within an established manufacturing site in Fermoy, Cork.

About Your New Job

As a Validation Engineer, you will own and support validation activities across a medical device manufacturing environment.

Your responsibilities will include:

• Managing assigned Process, Equipment, Facility, Utility, Software and Computer System Validation activities.
• Preparing Validation Plans, Protocols and Reports.
• Supporting the resolution of issues identified during validation activities.
• Ensuring a consistent validation and qualification approach across systems and projects.
• Providing guidance on the preparation and execution of validation activities.
• Maintaining the site validation system, including conducting periodic reviews.
• Participating in change control processes relating to manufacturing processes, equipment, facilities, utilities and computer systems.
• Supporting ongoing compliance with GMP, quality and industry regulatory requirements.
• Ensuring all activities are completed accurately and within agreed timelines.

This is an individual contributor role reporting to the Validation Quality Lead.

Important: You must currently live within commuting distance of Fermoy, Cork. Relocation support is not available for this position.

What Skills You Need

• A QQI Level 7 degree, preferably in Science, Electronics, Mechanical Engineering, Industrial Engineering or a related discipline.
• Experience working in a medical device manufacturing or pharmaceutical environment.
• At least one year of experience in Quality Assurance or Regulatory Affairs.
• Experience supporting or completing validation activities covering processes, equipment, facilities, utilities, software or computer systems.
• Experience with statistical analysis, Design of Experiments (DOE) and DMAIC methodologies.
• A sound understanding of problem-solving techniques and strong technical capability.
• Proficiency in Microsoft Word, PowerPoint and Excel.
• The ability to prepare standard operating procedures, training documents and regulatory responses.
• Experience using the GAMP 5 approach would be advantageous but is not essential.

What's on Offer

• A 6-month contract within a regulated medical device manufacturing environment.
• Salary of €80,000–€90,000, depending on experience.
• The opportunity to work on a broad range of validation activities across processes, equipment, facilities, utilities and computer systems.
• Valuable exposure to GMP, regulatory compliance, change control and site-wide validation systems.