Validation Engineer

Validation Engineer
We are seeking an experienced Validation Engineer to join our team and lead the development and maintenance of a robust Site Validation program. In this role, you will collaborate with key business stakeholders to ensure compliance with global regulatory requirements. The ideal candidate will possess a strong background in computer system validation, particularly within Class II/III medical device manufacturing, and will have a deep understanding of applicable global regulations and industry standards.

Responsibilities 
⦁    Partner with key business stakeholders to develop policies and procedures necessary to lead the implementation and maintenance of a compliant, efficient and integrated Site Validation program.
⦁    Draft, review and approve validation deliverables such as user requirements, technical design specifications, IQ/OQ/PQ scripts and reports, error logs, configuration document, traceability matrix and document 21 CFR Part 11 and EU Annex 11 compliance. 
⦁    Facilitate, prepare and execute Validation documents for Technical Operations, QA and R&D groups, as necessary. 
⦁    Develop Test Plan, Test Cases, Test Reports and Traceability Matrix as per business requirements 
⦁    Manage end to end testing / validation lifecycle and provide SME support on topics relevant to design Verification and validation (V&V) ,GxP, CSV, 21 CFR Part 11, EU Annex 11 etc. 
⦁    Coordinate with cross function departments to ensure Systems and software are validated for their intended use and solutions are implemented in an efficient and effective manner. 
⦁    Evaluate risks, maintain and implement quality systems to ensure compliance with applicable global regulatory requirements. 
⦁    Promote adherence to applicable policies and procedures governing computer systems, good documentation practices, and change management. 

What we are looking for…
⦁    Bachelor's/Master’s degree in Engineering, Science, Medical or related field.
⦁    A minimum of 3 years of experience in systems validation, hands on experience with validation of processes in medical device industry (particularly in Class II/III medical device manufacturing).
⦁    Strong working knowledge and experience of global regulations and guidelines such as GAMP5, 21 CFR Part 11, EU Annex 11 , 21 CFR Part 820, ISO 13485, etc. coupled with ability to practically apply such knowledge.
⦁    Proven experience developing full validation documentation and testing protocols (IQ/OQ/PQ/UAT) within the medical device development life cycle.
⦁    Define risk-based strategies for validation systems and develop end-to-end validation documentation in accordance with various test plans. 
⦁    Perform system risk assessments - GxP, Business, and Functional Risk Assessment, systems gap analysis, review and approve action plans to ensure compliance during and after the system validation. 
⦁    Detailed knowledge and understanding of statistical analysis ( Including minitab)
⦁    Experience in validating ERPs (E.g. SAP, Oracle etc).
⦁    Provide training related to validation to users and appropriate personnel within the organization.
⦁    Certification / experience in Operational Excellence / Six Sigma highly desired.

Benefits
Alongside base salary €50,000 - €60,000, we offer a range of benefits including: 
⦁    Health insurance and an Employee Assistance Programme 
⦁    Pension matching contribution
⦁    Annual Compensation Reviews 
⦁    After 90 days you will be eligible to avail of Flexible Annual Leave where you are not restricted to a specific number of holiday days / annual leave
⦁    Free monthly LetsGetChecked tests as we are not only focused on the well being of our patients but also the well being of our teams
⦁    A referral bonus programme to reward you for helping us hire the best talent
⦁    Internal Opportunities and Careers Clinics to help you progress your career within the company.  
⦁    Bike to work scheme - and secure bike storage onsite. 
⦁    Maternity, Paternity, Parental and Wedding leave.