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Job ID: JOB-12599
Validation Engineer I or II
Hybrid
Location: Galway

As our newest member of the Validation Engineering team, you will participate in exciting and varied projects, acting as a technical SME for validation activities. In your new role, you will manage aspects of equipment, and computerised system validation for any software system used to manufacture medical devices. So if you are interested in a rewarding career as a Validation Engineer and ready to join a team focused on innovation and delivering a first class service, read on for more information and start the application today.

Key Activities of the Role:

• Prepare software validation protocols for the Equipment Engineering group. Execute these protocols and ensure sign-off is obtained at each stage.
• Review Equipment Function specs and provides direction and support on validation strategy and plans.
• Work with the Quality department to ensure equipment validations are in line with global & Site validation standards.
• Ensure regulatory compliance with global software validation requirements.
• Ensure Computerised system validation procedure(s) are kept up to date and maintained.
• Take responsibility for correctly carrying out and maintaining all validation and associated documentation for equipment.
• Provide software validation/compliance guidance and training to staff across various functions as required.
• Develop and enhances cross-functional team relationships and work cross-functionally to identify and resolve technical and organisational issues.
• Ensure the Equipment Engineering Group employs best validation practices to maximise effectiveness and minimise non-value-added work.
• Communicate effectively & efficiently with cross-functional teams on project tasks
• Actively pursues continuous improvement.
• Complete project deliverables and monitor project schedule and scope changes to assure the team can meet delivery requirements for related projects.
• Generate quotations, concepts and business cases for new and upgraded software systems.
• Take part in or lead sustaining projects to support business goals and objectives.

Qualifications and Experience

• NFQ Level 8 qualification in a STEM discipline.
• Minimum of 3-5 years experience in a Validation role within a medical device, biotechnology or pharmaceutical manufacturing organization or equivalent.
• Proven track record and performance executing validation activity independently or as part of a team in multiple areas.
• Availability to travel as required.
• Ability to support weekend work as required.

For further information on this  role in Galway please contact Emma Griffin on +353 860334325 or email quality@hero.ie Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Emma Griffin

JOB-12599

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