Job details
Job type contract
Full job description
Responsibilities:
As a senior staff validation engineer, you will be participating in the definition of the stryker validation strategy to be outlined in corporate procedures and based on regulatory requirementsResponsible for local validation teams in terms of technical expertise and definition of best practicesSupporting validation activities by providing guidance and expertise to authors of validation documentation and executors of validation protocols at several sitesReviewing and approving of validation documentation to ensure compliance with regulations and validation best practices.
This person 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.
Being subject matter expert in more than 1 validation specialty for development of corporate procedures and work instructions.
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.
Mentoring for graduate validation engineers
Establish validation standards in terms of industry best practices and drive this level across the organization
Having multi-site responsibility for at least 1 validation specialty.
Requirements:
Bachelor`s degree is required.
Minimum 6+ years` experience working in quality, manufacturing, engineering, validation or highly regulated environment.
Bachelor`s degree in science or engineering strongly preferred.
Expert knowledge of computer system validation including gamp 5 and 21 cfr part 11 requirements desirable.
Working knowledge/experience of risk based techniques i.eFmeas, ftas etc.
Have a good understanding of statistical techniques, in particular statistical sampling plans, process capability, gauge r&rs.
Lean six sigma training a distinct advantage.
Excellent knowledge of all validation elements (all validation documents and specialties).
Expert knowledge in at least 1 validation specialty.
Strong knowledge of quality concepts (e.gCapa, audits, statistics).
Thorough knowledge and understanding of international medical device regulations.
Experience in working in a compliance risk situation.
Experience in interacting with regulatory agencies (fda, tu v, etc.).
Highly developed problem solving and strong analytical skills.
Mentor or trainer for validation subjects.
Qualification in statistical techniques.
Project management training or skills.
