Validation Engineer

R.T.Lane Recruiting Talent

Cork

R.T Lane Recruitment are currently recruiting for a Validation Engineer for a Global Medical Device company based in Cork. This company prides itself by the acknowledgement, that the key to their business success is their staff and so in turn, they offer a very competitive salary plus other bonus; e.g. healthcare and pension etc. which are designed to support the lifestyles of their employees and the people that matter most in their life’s. One of your main responsibilities will be to come up with leaner ways of doing validations also, and making the review/approval more efficient and will need to be comfortable in a fast-paced environment where deadlines are always met. You will have the primary responsibility for Quality Assurance activities associated with :- - Equipment Qualification and Process Validation. - Facility & Utility Validation. - Method Validation. Have knowledge of and ability to provide Interpretation and Guidance on Regulations, Corporate, Divisional and Site Local procedures as they relate to validation activities. Participate on both Corporate and Divisional Validation Teams to discuss/feedback and approve revisions to Validation Procedures. Represent validation at both internal and external audits. Ensure that QE’s and Validation Practitioners receive training/coaching to allow them to effectively support and/or perform validations for current and anticipated projects. Ensure that Appropriate Systems are in place to evaluate changes to Validated/Qualified Systems to ensure their continued validated/qualified state. Ensure that appropriate Site Validation Listing is established and controlled as per Current Regulatory and Company Requirements. Review/Approval of Validation/Qualification Documentation. Ensure that Validation Logging System is maintained, tracking Validations, Validation Files and ensuring accessibility when required. Assist in the evaluation of the validation status of contract manufacturers and provide guidance where needed. Review validation documentation from contract vendors ensuring that company requirements are met. Work with Validation Consultants/Contractors as required ensuring that Validations are completed as per corporate and divisional procedures. Qualifications Typical Minimum Education: Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline. Typical Minimum Experience: 3+ yrs, considerable experience in a comparable role: someone who would typically have experience operating as a senior professional and adding considerable value to the business; in a GMP manufacturing setting. in a healthcare/GMP manufacturing setting. For a more detailed job spec and information on this role and others, please contact Anne Gough on 022 26006 TODAY! This job originally appeared on RecruitIreland.com.

2657 days ago