Senior Validation Engineer
Would you like to work for a company that produces products that both enhance and saves lives?
Do you have a Bachelor of Science, Engineering & 2 years + validation experience or a Masters of Science, Engineering & 1 years+ validation experience?
Do you have a strong understanding of engineering and machine tool fundamentals allied to a working knowledge/experience of Risk Based Techniques and a good understanding of statistical techniques?
If so this may be the job for you!
Our client one of the world's leading med tech companies are currently recruiting for a Validation Engineer for their Cork plant. Guided by their values of delivering to their customers and clients, doing what's right, growing talent and delivering on what they promise a job here is truly an opportunity to make a real difference to people's lives.
Working within the QA Shared Services Validation Team, you will be responsible for validation related activities, including
Providing interpretation and Guidance on Regulations, Corporate, Divisional and Site Local procedures as they relate to validation activities.
Participating within the Corporate Validation Team to develop and revise Validation Procedures & Templates to ensure that Current Regulatory Compliance and Company Objectives are maintained.
Participating on both Corporate and Local Validation Teams to discuss / give feedback and approve revisions to Validation Procedures.
Representing validation at both internal and external audits.
Ensuring that Validation Practitioners receive training/coaching to allow them to effectively support and/or perform validations for current and anticipated projects.
Ensuring that appropriate Systems are in place to evaluate changes to Validated/Qualified Systems to ensure their continued validated/qualified state.
Ensuring that appropriate Site Validation Listing is established and controlled as per Current Regulatory and Company Requirements.
Reviewing and approving of Validation/Qualification Documentation.
To hit the ground running in the validation engineer role you will definitely need to have a strong knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics) along with highly developed problem solving and strong analytical skills.
A background in Lean Six Sigma and a knowledge of Computer System Validation including GAMP 5 and 21 CFR part 11 requirements would be desirable.
In return you will get the opportunity to work in a cutting edge world class manufacturing environment where the demands are great but where there is ample opportunity to progress your career and advance your technical expertise with an employer that put a premium on talent development and employee engagement. You also get the opportunity to work with a company that both enhances and saves lives.
Please click on the link or if you would prefer to have an informal and confidential chat before applying please contact Feargus Young on 086 020 2554
Alternatively, you can connect with me on http://bit.ly/2aNqmls or https://twitter.com/FeargusYoung