Senior Engineer, Validation in Carrigtohill at Stryker Corporation

Date Posted: 7/1/2019

Job Snapshot

Job Description

Position Summary

Will work within the QA Shared Services Validation Team, responsible for validation related activities, including, but not limited to the following:

  • Having knowledge of and ability to provide Interpretation and Guidance on Regulations, Corporate, Divisional and Site Local procedures as they relate to validation activities.
  • Participating within Corporate Validation Team to develop and revise Validation Procedures and 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.
  • Working with Validation Consultants/Contractors as required ensuring that Validations are completed as per corporate and divisional procedures.
  • Being the site responsible for at least 1 validation specialty and be the primary support for that specialty and site.

What are we looking for?

  • Bachelor of Science, Engineering or related subject and 2 years of experience in validation, or

Masters of Science, Engineering or related subject with 0 to 2 years of experience in validation

  • Excellent communication skills and attention to detail
  • Have a good understanding of engineering and machine tool fundamentals.
  • High level of PC skills.
  • Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
  • Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
  • Must be willing to work as part of a multi-site team, be able to travel as part of the job
  • Knowledge of Computer System Validation including GAMP 5 and 21 CFR part 11 requirements desirable.
  • Working knowledge/experience of Risk Based Techniques i.e. FMEAs, FTAs etc.
  • Have a good understanding of statistical techniques, in particular statistical sampling plans, Process Capability, Gauge R&Rs.
  • Strong knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics).
  • Highly developed problem solving and strong analytical skills.
  • Lean Six Sigma training a distinct advantage

Work From Home: No

Travel Percentage: None

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