Validation EngineerLocation: LimerickWorking mode: Hybrid, 3 days on-site and 2 WFHDuration: 12 monthsHours: 39 hours per weekPay rate range: Competitive hourly rate (PAYE, Umbrella and Ltd options available)This role is to support the activities of JJVC Materials and Supplier Engineering (MSE) function in assuring compliance with applicable regulations and procedures.Develop Validation Documentation to support new / revised materials and suppliers for their associated process/product qualifications and provide support to existing business continuity and process improvement requirements.roles and responsibilitiesResponsible for assuring compliance to applicable regulations and procedures while at the same time attaining operational effectivenessWork with the various departments/groups in development and execution of validation activities associated with new / revised materials and suppliersDesigns and develops validation documentation to support business continuity, new process introductionsImplementation and co-ordination of the change control process, promotes timely approval of all supporting documentationLeads and coordinates cross functional teams to drive business and organizational results for MSE’s business continuity planning (BCP) projects.Supports raw materials complaint investigations and resolution of sameProvides assistance to other departments with trouble shooting problems, deviations, discrepancies and non-conformances.how to succeedA Bachelor’s degree: Engineering or Science in a Manufacturing / Chemistry / Materials / Packaging / Natural / Physical Science related field, from accredited college3-5 years in a Quality function within the Medical Device/ Pharmaceutical industry.Essential:Have good knowledge of statistical techniques in the use of problem solving/ data analysis.Have a proven track record in development/execution of Validation programs in areas of equipmentProcess Information managementAbility to demonstrate standards of leadership – Managing Complexity/CredoFlexible and a Team PlayerGood Influencing / Communication SkillsProject Management SkillsGood generalistMethodologicalDesirable:Be very familiar with relevant regulatory standards (e.g. FDA Quality System Regulation, ISO 13485, EU MD Directive/Regulations, FDA Combo Product Regulation 21 CFR Parts 4 with 21 CFR 210/211 as applicable, Japanese MHLW, Health Canada, Brazilian ANVISA, Australian TGA) applicable to the manufacture of Class II and Class III medical devices to Global markets.Familiar with use of Microsoft Office and Statistical Analysis (e.g. Minitab) software products.benefitsThis role offers a very competitive hourly rate. This contract will initially run for 12 months.you are welcome hereJohnson & Johnson Vision is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.about Johnson & Johnson VisionJohnson & Johnson Vision brings together cutting-edge insights, science, technology and people. We partner with eye care professionals and help more people around the world preserve and restore sight. Our portfolio includes the best selling contact lens brand in the world, ACUVUE, plus consumer eye health solutions, dry eye treatments, refractive (Lasik) and cataract products. Contribute to the next healthcare breakthrough, create a world connected by SIGHT with your next project at Johnson & Johnson Vision.application processWe are looking to process the first round of applications within the next 2 working days.We do not accept applications via email. The pay rate for this role will depend on how you are paid. PAYE, LTD & Umbrella options are available.Diversity, Equity & InclusionFor more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.
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