Computer System Validation (CSV)

Location: Greater Boston Area

Job Description


Computer System Validation (CSV) professionals develop, review and conduct activities related to the validation of computer systems and processes to establish and ensure compliance. This involves all regulated systems through their life cycle including planning, requirements, specification, design, test, install and verification. Duties include:
  • Review and evaluate computerized system validation (CSV) strategies, policies, standards, processes, SOP’s and other documents and provide guidance and counsel as needed.
  • Develop and perform all CSV activities, documentation requirements and reports including plans, risk assessments, function requirements, configuration specifications, testing, change controls, traceability matrix, qualification protocols, validation and compliance reviews.
  • Develop and complete deliverables as needed and in line with project/business objectives.


Qualifications

  • College degree or equivalent work experience; minimum three years of system validation experience in an FDA or related regulatory environment is needed.
  • Effective organization, communication and interpersonal skills and the ability to manage priorities in a time sensitive environment.
  • Proficiency using computer software and systems related to performing system/equipment activities; experience with systems (e.g. SAP, Salesforce, Documentum, Trackwise, or specific MES/ERP/LIM system(s))