Senior Systems Validation Lead

2 weken geleden

Drachten, Friesland, Nederland BD Kiestra Voltijd

Position Overview

The Lead System Verification and Validation role is pivotal in ensuring the integrity and compliance of our products at BD Kiestra. This position encompasses the responsibility for all verification and validation (V&V) activities related to both software and hardware systems.

Key Responsibilities

  • Oversee system V&V activities for complex projects, ensuring adherence to regulatory standards.
  • Participate actively in risk management discussions to mitigate potential project risks.
  • Develop comprehensive System V&V plans and summary reports for project stakeholders.
  • Act as the CAPA owner or task owner, driving accountability and resolution.
  • Implement effective system validation strategies and principles to enhance product quality.
  • Foster functional excellence through cross-site benchmarking, mentoring, and training initiatives.
  • Assist in resource allocation across various projects, aligning personnel capabilities with project needs.
  • Maintain clear communication with project leads regarding progress and the status of validation activities.
  • Promote a culture of continuous improvement in systems and processes, emphasizing quality and execution.
  • Collaborate closely with project leads, fellow engineers, developers, and functional analysts to ensure project success.
  • Ensure the accurate use of tools and systems to support validation efforts.

Qualifications

  • Bachelor's or Master's degree in a relevant engineering discipline.
  • A minimum of 5 years of experience in verification and validation, preferably within the medical device, pharmaceutical, or biotechnology sectors.
  • Experience in project management, particularly in new product development initiatives.
  • Familiarity with working in a Quality Management System (QMS) regulated environment.
  • Proven ability to manage both technical and non-technical stakeholders effectively.
  • Demonstrated success in implementing change within projects and processes.
  • Strong influencing, persuasion, and communication skills.
  • Excellent organizational and scheduling capabilities.
  • Proficient command of the English language.

About BD Kiestra

BD Kiestra is committed to advancing the world of health through innovative medical technology solutions. Our culture fosters growth, inclusivity, and a commitment to excellence in all that we do.

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