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Evotec

FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap. ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.

IT CSV Engineer

Location

Washington

Posted

11 days ago

Salary

$115K - $135K / year

Seniority

Senior

Bachelor Degree5 yrs expEnglish

Job Description

IT CSV Engineer

Evotec

• Lead validation efforts for Manufacturing (MFG), Quality Control (QC), enterprise, and PP&D systems within the Sandoz remediation initiative. • Ensure adherence to client requirements, regulatory compliance, and project timelines. • Collaborate with cross-functional teams to execute complex Computer System Validation (CSV) projects, including remediation and new system implementations. • Develop validation strategies and author validation documents such as validation master plans, data migration plans, protocols, reports, and discrepancy resolutions. • Manage and optimize validation testing processes, ensuring risk-based validation approaches align with current FDA Computer Software Assurance (CSA) principles and GAMP5 practices. • Standardize and enhance CSV framework templates and procedures to drive continuous improvement initiatives. • Support and oversee risk management activities, including risk-based assessments and gap remediation efforts. • Ensure compliance and maintain the validated state of all GxP systems. • Manage external CSV consultants and oversee their contributions to CSV projects. • Serve as a subject matter expert (SME) for Data Integrity, CSV lifecycle management, and compliance with global regulatory expectations. • Own CSV-related deviations and CAPAs, managing remediation efforts related to CSV and Data Integrity. • Partner with IT to establish backup/restore protocols, disaster recovery strategies, adherence to data retention schedules, and infrastructure qualification requirements. • Assist business and technical owners in developing requirements and specifications for computerized systems used in GxP operations. • Oversee the authoring and execution of IQ, OQ, and PQ test scripts.

Job Requirements

  • Strong experience with GxP computer systems validation and compliance.
  • In-depth knowledge of GxP regulations and CSV/CSA principles, including but not limited to 21 CFR Part 11, Annex 11, GAMP 5, and Data Integrity.
  • Experience with Quality Risk Management (ICH Q9) and its application in CSV.
  • 5+ years of experience in GxP CSV roles.
  • Thorough understanding of validation/qualification concepts within pharmaceutical quality systems.
  • Strong technical writing skills for validation documentation and compliance reporting.
  • Excellent communication skills (both oral and written) with the ability to effectively interact across organizational levels and functions.

Benefits

  • discretionary annual bonus
  • comprehensive benefits to include Medical, Dental and Vision
  • short-term and long-term disability
  • company paid basic life insurance
  • 401k company match
  • flexible work
  • generous paid time off and paid holiday
  • wellness and transportation benefits

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