Senior Process Validation Engineer

Sigmar Recruitment

Galway

Senior Process Validation Engineerv. At our Process Validation Department, we focus on providing process validation support during the full lifecycle of the product. The Quality Engineer is directly involved in the initial development of new products to ongoing support when products have been commercialized we ensure that the performance and safety of the devices we support is maintained through the product lifecycle.   Responsibilities: As part of a cross-functional team, provide Quality Engineering technical direction/input to the process validation activities post commercialization. Provide expert QE technical direction/input to qualification and validation activities in conjunction with Engineering and extended QA teams to ensure quality standards are in place. Completes test method validation for methods and procedures used for inspecting, testing and evaluating the precision and accuracy of products, test and production equipment. Support the introduction/implementation of process/materials changes to the manufacturing operation. You will assess the impact on process validation for these changes. Function effectively as part of cross functional teams; develop strong partnering relationships within these groups and provide constructive feedback and quality leadership. Understand product construction, features and uses at a highly competent level to contribute to decision making process on product acceptance standards within their scope of responsibility. Lead or support root cause investigations; drive problem solving efforts for quality issues. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements • Provide on-going communication, information transfer and record keeping in support of business and core-team objectives and metrics.   Experience: We are looking for a person qualified to Minimum of a Bachelor’s degree (Level 8 NFQ) in a relevant technical discipline (e.g. Engineering, Science) and desirably with a minimum of 5 years relevant experience. You are a dynamic team player, can work effectively and proactively on cross-functional teams. Initiates and Leads Change, Collaborates and Creates Alignment, Drives Accountability and Thinks Critically and Makes Sound Decisions. Knowledge of regulatory requirements and guidelines including 21 CFR parts 210, 211, 21 CFR part 820, ICH requirements and ISO 13485 requirements is an advantage. Knowledge of combination products, statistical requirements or software validation requirements is an advantage. You are a good communicator and fluent in English, both in writing and speaking.   To apply for this position please contact Chloe Walsh at Sigmar Recruitment T: +353 91 455305 E:   chloe.walsh@sigmar.ie   All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent.  .

1103 days ago