Medical Device 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

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;