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Validation Specialist in CSV

2 months ago

Chula Vista, California, United States Katalyst Healthcares and Life Sciences Full time
Key Responsibilities:
  • Collaborate with project managers and client teams to grasp the overarching goals of projects.
  • Develop validation strategies, user requirements documentation, system specifications, risk assessments, testing protocols, traceability matrices, data migration strategies, and change documentation.
  • Create and evaluate testing plans and scripts (IQ/OQ/PQ), implement test protocols, compile test summary reports, and finalize validation documentation.
  • Oversee and preserve electronic records within the client’s document management system to ensure adherence to regulatory standards.
  • Assist in the upkeep and improvements of the client’s tailored integration between Veeva QualityDocs and Cornerstone.
  • Engage with client personnel to confirm that validation activities and outputs align with corporate policies and procedures.
Required Qualifications:
  • Bachelor’s degree from an accredited institution; advanced degrees and certifications (e.g., PMI-PBA, CAPM, PMP) are highly preferred.
  • Minimum of 5 years of pertinent experience in a computer system validation role within the biotech or pharmaceutical sectors; familiarity with relevant regulations and guidelines (e.g., Title 21, GxP) is strongly preferred.
  • At least 3 years of relevant experience with Cornerstone On Demand; additional experience with Compliance Wire, Veeva Quality Docs, SQL, and Python is advantageous.
  • Strong foundation in project management and system validation methodologies, with excellent expectation management skills.
  • Proven ability to manage multiple projects and competing priorities while delivering high-quality results.
  • Comprehensive understanding of a Risk Management-Based Approach to system validations, including system risk categories and classifications (GAMP 5).
  • Familiarity with 21 CFR Part 11 and Annex 11 regulations.
  • Knowledge of regulations concerning personal and patient data privacy (GDPR).
  • Experience in leading validation projects.
  • Proficient in authoring validation plans, user requirements documentation, system specifications, traceability matrices, testing plans and scripts (IQ/OQ/PQ), executing test plans, and preparing final validation reports.
  • Experience with Electronic Document and Quality Management Systems such as Veeva, Qualio, or Master Control is highly desirable.
  • Background in test coordination and management, including training users on executing test protocols and overseeing test results throughout the process.