Job Id
291234
Carrigtwohill, Cork, Ireland
Job Type
Full-time
Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimaginable with us.
The Role
Reporting to the Principal Validation Engineer, the Validation Engineer is responsible for the design and execution of validation project and strategies to support the implementation of Validation Master Plans and Qualification programmes.

Duties:

• Responsibility for the validation of manufacturing and all associated processes for the new manufacturing facility located in Blarney.
• Execute and complete process, systems and equipment validations in accordance with Validation Master Plans, company policies and project schedules.
• Prepare, execute and complete Validation Protocols and Reports, ensuring compliance to all relevant Quality standards and Regulatory requirements, particularly irradiation sterilization.
• Participate in cross-functional teams to establish validation strategies and objectives to support process and equipment changes.
• Ensure all departments understand and comply with requirements defined in validation programmes, provide training as necessary.
• Maintain ongoing understanding and knowledge of requirements for validation in compliance with applicable regulations and guidance documents, provide updates to department management and cross-functional teams.
• Participate in the review of validation practices and trends, identify opportunities for continuous improvement and complete improvement projects.
• Monitor the progress of validation projects to ensure adherence to schedule and provide regular stakeholder updates.
• Ensure thorough investigation of Quality and Validation issues using Root Cause Analysis methodology and implementation of robust corrective and preventative actions to prevent recurrence.
• Lead and co-ordinate Risk Mitigation initiatives such as FMEA and Risk Assessments.
• Adhere to all company EHS guidelines and Quality procedures.
• Perform other duties as required.

Who You Are
B.Sc. in an appropriate Science/Quality Assurance discipline or equivalent
Strong understanding of cGMP, ISO, and other relevant regulatory standards, particularly ISO 11137 and ISO 11737.
Thorough, practical and persistent self-starter with strong motivation
Good verbal and presentation skills
Strong written communication skills with proven technical and report writing skills
Demonstrated success working in a team environment
Effective time-management skills to meet project schedules
Good problem-solving skills
This role involves travel abroad.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology. We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!
US Equal Employment Opportunities
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
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• Responsibility for the validation of manufacturing and all associated processes for the new manufacturing facility located in Blarney.
• Execute and complete process, systems and equipment validations in accordance with Validation Master Plans, company policies and project schedules.
• Prepare, execute and complete Validation Protocols and Reports, ensuring compliance to all relevant Quality standards and Regulatory requirements, particularly irradiation sterilization.
• Participate in cross-functional teams to establish validation strategies and objectives to support process and equipment changes.
• Ensure all departments understand and comply with requirements defined in validation programmes, provide training as necessary.
• Maintain ongoing understanding and knowledge of requirements for validation in compliance with applicable regulations and guidance documents, provide updates to department management and cross-functional teams.
• Participate in the review of validation practices and trends, identify opportunities for continuous improvement and complete improvement projects.
• Monitor the progress of validation projects to ensure adherence to schedule and provide regular stakeholder updates.
• Ensure thorough investigation of Quality and Validation issues using Root Cause Analysis methodology and implementation of robust corrective and preventative actions to prevent recurrence.
• Lead and co-ordinate Risk Mitigation initiatives such as FMEA and Risk Assessments.
• Adhere to all company EHS guidelines and Quality procedures.
• Perform other duties as required