Sr. Validation Engineer
California, San Francisco
Our client, a Global Medical Device Manufacture has an immediate opening for a Sr. Validation Engineer for a 6 Month + Contract. Our client offers results-driven people a place where they can make a difference every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.
Position Description (Principle Duties and Responsibilities)
Role will be responsible for Implementing a validation strategy, based on Corporate procedures and regulatory requirements. Additionally, supporting validation activities by providing guidance and expertise to authors of validation documentation and executors of validation protocols at the local site.
Reviewing and approving of validation documentation to ensure compliance with regulations and validation best practices.
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.
Bachelor of Science, Engineering or related subject with 3 to 5 years of experience in validation, or Master of Science, Engineering or related subject with 0 to 2 years of experience in validation
Have a good understanding of engineering and machine tool fundamentals.
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.
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