IT Computer Systems Validation Specialist

City
Durham

State
NC

Job Type
Full-Time Regular

Job Description

Bull City Talent Group is seeking a junior to mid-level Computer System Validation Specialist for an immediate opening with one of our clients in the Durham, NC area.

Job Summary:

This role requires assisting in computer system validation efforts, supporting quality system governance, and ensuring all work is carried out in compliance with cGMPs, company policies and procedures, 21 CFR Part 11, EU Annex 11, ICH guidelines, and other applicable industry regulations.

Roles & Responsibilities:

  • Computer system administration
  • Provide technical/end user support for computer systems
  • Maintain close communication with management to keep stakeholders apprised of computer system incidents/resolutions, project validation states, and other relevant issues
  • Perform administrative duties for analytical systems within lab
  • Assist in configuration and validation of new systems
  • Create and execute validation protocols
  • Analyze data and results to verify that acceptance criteria for validation protocols are met
  • Execute assigned investigation tasks, change control activities, gap assessments, CAPA deliverables, and periodic reviews
  • Ensure project deadlines and performance standards are met
  • Develop and maintain current understanding of FDA and EU regulations as they pertain to CSV and compliance
  • Support controlled access to all validated quality computer systems
  • Gather and record all data and information in accordance with cGMP requirements

Qualifications:

  • 2-5 years of CSV and/or system administration experience
  • Experience in Pharmaceutical/Biopharmaceutical industry
  • Experience in laboratory information management systems (Waters Empower 3, CDS, LIMS, ELN, etc.)
  • CompTIA A+, Network+ certifications
  • Experience with MS technology associate networking, security, Windows 7, and server
  • Experience with relational database systems (Oracle, SQL, Server, etc.)
  • Experience with MS Office Suite
  • Strong communicator
  • Strong math and reasoning abilities

For immediate consideration, please reach out to BrettR@bullcitytalent.com

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