Computer Systems Validation Lead

3 weeks ago

Rockville, United States Quality Agents Full time
Job DescriptionJob DescriptionSalary: TBD

Quality Agents, LLC offers validation and quality expertise to the pharmaceutical and biotechnology industries. 




Our Computer Systems Validation Leads work directly with our clients to support activities that include, but are not limited to, documentation review and approval, including change controls, assessment plans, risk assessment reports, compliance plans, user requirements, system and user acceptance testing protocols, traceability matrix, error reports/defect report forms and summary reports. The individual will contribute directly to the completion of projects through the management of assigned contract personnel, development and execution of validation change control documents, and development and review of protocols, reports and data tables generated by peers and contract personnel. Responsibilities include:


  • Optimization of CQV support process, including developing including developing standards and KPI reports.
  • Compile and analyze validation data and make recommendations for changes and/or improvements
  • Maintain all documentation pertaining to computer systems validation
  • Data integrity qualification
  • Participate in cross-functional project teams including development & deployment teams as well as customer Manufacturing, Engineering, Quality and other groups
  • Some travel is required




Skill level & requirements:


  • Experience with IQ, OQ, PQ Final reports relating to Computer Systems Validation.
  • Experience writing validation master plans.
  • Experience with Configuration, design, data and traceability matrices.
  • Validation experience with automated systems is preferred
  • Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11
  • Strong knowledge of computerized system development life cycle approach is required
  • Strong leadership skills and the ability to work in cross-functional team environments, as well as independently
  • Experience coordinating Quality documentation, specifically qualification/Validation documentation
  • Demonstrated excellent leadership/Project Manager skills
  • Strong technical writing skills
  • Excellent written and verbal communication skills
  • The ability to work and make decisions independently and have the flexibility to adapt to changing priorities is required




Minimum Requirements:


  • Bachelor’s degree in a technical discipline (i.e. Engineering, Chemistry, Microbiology, Biology)
  • 3 – 5 years Computer Systems Validation background
  • 3 – 5 years IT Quality Assurance / Validation experience
  • Current driver’s license and auto insurance or other means of independent transportation




Quality Agents offers a full suite of benefits for full-time employees including:




  • Health, dental and vision insurance
  • Life, AD&D and Disability Insurance
  • Health savings account for participants in our health plan
  • 401k retirement plan
  • Paid time off
  • Paid holidays


Quality Agents accepts applications on an on-going basis in order to build a talent pool of potential candidates. These applications remain open for consideration, as positions become available, for one (1) year from the date of application. After that time, or if your application information changes, please submit your application again.

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