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Computer System Validation Specialist

Redwood City, CA
Title: Computer Systems Validation Specialist
Type of role: Contract 12+ months
Location: Redwood City, CA

This person will be responsible for validation services and providing support for IT and Clinical GxP systems. This role will be responsible for providing application support for IT GxP systems and Clinical systems, and participate in business requirements, analysis, implementation, computer systems validation, retirement of Computer systems for all IT GxP related systems
*(Prefer experience with cloud-based applications)
Position Responsibilities
  • Responsible for providing application support for IT GxP systems and Clinical systems - cloud based
  • Perform Computer System Validation (CSV) support activities (i.e. document creation assistance, protocol execution)
  • Provide Technical Writing activities (i.e. writing Standard Operating Procedures and Validation documents)
  • Assess, and provide application solutions and recommendations to all levels of management.
  • Create and execute Installation Qualification (IQ), Operation Qualification (OQ), Performance qualification (PQ) documents for GxP applications.
  • Collaborate with Global Quality team to develop project validation documentation and test plans.
  • Ability to execute protocols, perform testing sequences and change controls.
  • Provide day to day and scheduled application support; respond to application support issues from multiple business customers.
  • Field incoming problem tickets from end users to resolve enterprise applications and software issues for GxP applications.
  • Test fixes and perform post-resolution follow-ups to ensure problems have been adequately resolved.
  • Bachelor's Degree in Computer Science/Business Administration or an equivalent level of education and experience.
  • 3-4 years of experience in supporting GxP and related systems and validation of GxP systems including implementation, retirement and maintenance of GxP systems.
  • Knowledge and experience working within an SDLC framework.
  • Demonstrated experience working in a regulated environment including a thorough understanding of 21CFR Part 11.
  • Prior experience working in the Life Science industry including pharmaceutical, biotechnology or medical devices.
  • Experience with the following types of systems preferred: Stability LIMS, Quality Management Systems, LMS and eTMF.
  • Excellent organizational, interpersonal and customer service skills; excellent communicator with active-listening skills.
  • Proven adaptability to shifting project schedules, priorities and assignments; able to make effective decisions under pressure.
  • Demonstrated problem-solver in a dynamic, fast-growing team environment.
  • Strong written and oral communication skills.
  • Strong presentation and interpersonal skills.
  • Exceptional analytical, conceptual and problem-solving abilities.
  • Able to prioritize and execute tasks in a high-pressure environment.
  • Highly motivated with the ability to drive results.
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