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Validation Engineer

Company: Sigmaways Inc
Location: Santa Clara
Posted on: November 19, 2021

Job Description:

The Role : This role supports strategic projects and programs (e.g. IVD product launches, RUO to IVD, IVD readiness, etc) by ensuring production sites have all necessary prerequisites needed to prepare, approve, and execute detailed validation protocols that meet the relevant testing standards per global and local requirements.
Responsibilities :

  • Must be adept at managing stakeholder relationships and ensuring clear and timely communication for partners in the project, including identifying and resolving risks and facilitating agreement.
  • Critical to the role is to seek out relevant discussion points to fully define and constrain a comprehensive validation strategy for the project.
  • Confident, clear, and concise communication is necessary for success in this role: in writing, verbally, and using electronic collaboration tools.
  • Must have a thorough knowledge of IVDD requirements, and familiarity with IVDR.
  • A key focus for the role is to orchestrate validation-related activities supporting RUO to IVD, IVD readiness, and/or IVD strategic projects and programs as well as to successfully meet all validation-related milestones for the projects.
  • Develop the strategy and framework for ROU to IVD, IVD readiness, IVD initiatives in RSS.
  • Interface between project lead, senior management, and project core team members by communicating technical input, feedback, concerns, risks, and key decisions and by cascading decisions, guidance, and input.
  • Provide technical expertise needed to successfully complete validation deliverables and foster stakeholder alignment (e.g. Quality, MSAT, Development, Manufacturing, QC, Commercial, etc.)
  • Identify efficiency and optimization opportunities. The role will be a key interface or bridge between development and operations, and will work with RUO, ROU to IVD, and/or IVD products.
  • Raise CAPAs, NCRs, and Change Requests where required and assist with investigations.
    Qualifications :
    • BS Science or Engineering diploma/ degree; or certificate in a scientific discipline.
    • Minimum seven years of demonstrable experience related to leading local and/or global strategic projects and validation plans development.
    • Experience in the previous process, test method, and cleaning validation, as well as an understanding of process characterization
    • Validation and qualification experience in equipment, utilities, facility, shipping, and computer system validation will be advantageous
    • Must be from the diagnostic/pharmaceutical/biotech industry.
    • Ability to influence, negotiate, and communicate effectively at all levels of the organization in verbal and written form, including technical/business writing.
    • Working knowledge of ISO Quality Management systems would be preferred.
    • Personal Competencies: Work independently or in collaboration with others, strong work ethic, communication skills, planning and organizing, problem analysis and solving, effective time management, accountability.
    • Interpersonal Competencies: Good communicator, team player, change management, motivating, professionalism.
    • Managerial competencies: Sense of urgency, assertiveness.

Keywords: Sigmaways Inc, Santa Clara , Validation Engineer, Engineering , Santa Clara, California

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