Experienced Validation Engineer (Biotech) Carlow

SUMMARY: Experienced Validation Engineer required for a leading Biotech facility in Carlow, to provide process, technical, and validation support operations including ongoing support of manufacturing processes and support for new product introduction. Initially an 11 month contract. Contact Claire Ext 105
ROLE:
Accountable for analytical/engineering studies associated with the development of new components, products, processes systems and facilities.Co-ordination, design and execution of equipment qualification. and validation as required.Serve as technical and/or validation support as required for manufacturing and new product introduction. Design/Author/Review/Approve/Execute process development studies in support of new product introduction and ongoing manufacturing support. Provide technical input into quality notification by authoring/reviewing/approving investigations. Execution of equipment commissioning and qualification programs Execution of equipment/qualification validation programs; including re-qualification and revalidation Design/Author/Review/Approve/Execute qualification/validation documentation and studies in line with the standard approval process Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis Support continuous improvement through Lean Six Sigma methodologies.Leading and active participation in projects, system failure investigations and investigation reports, Execution/development of change controls Contribution to Kaizen events as appropriate. Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; Implement subsequent corrective action through the change management system. REQUIREMENTS:
Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline At least 6-7 years experience, ideally in manufacturing, preferably GMP Setting Relevant experience and a particular skill set in their area of expertise that adds value to the business; ideally in a manufacturing, preferably in a GMP setting Considerable experience in a comparable role: would typically have experience operating as a senior professional and adding considerable value to the business; in a GMP manufacturing setting. Demonstrated technical leadership and delivery of complex cross functional / cross site projects. SME in multiple aspects of aseptic processing.Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices Report, standards, policy writing skills required Equipment and process validation  Sterile filling processes and equipment Proficiency in Microsoft Office and job related computer applications requiredLean Six Sigma Methodology experience desired
Skills:
Validation ENgineering Science



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