Computer System Validation Engineer

Job Description

Computer System Validation Engineer

The CSV Engineer will oversee the GxP computerized systems validation and provide guidance to end-user community. The individual ensures that GxP systems meet regulations, current industry standards, and company procedures. This position is hands on CSV role and this individual will interact with solution and service providers, support or participate in internal/external audits, and assist in FDA readiness. This position frequently interacts with customers and other groups at the Site and coordinates the Computer System Validation tasks.

Responsibilities:

• Guides the work efforts of consultants and other team members, and mentors them in all areas of computer system compliance and validation.
• Develop and implement CSV and Data Integrity processes to ensure compliance with GxP, GAMP, OECD and applicable regulations in conjunction with operations counterpart.
• Responsible for providing input for maintaining the IT Master Inventory of Electronic Systems.
• Lead CSV projects, provide guidance to the business users and contractors/vendors.
• Coordinates, performs, an assist in the development of computerized system life cycle documentation and tasks to establish computerized systems that meet requirements. Perform various assessments (gap analysis, 21 CFR Part 11 assessment, GxP assessment, and Risk assessment), prepare user requirements, functional and configuration specifications, traceability matrix, test scripts, validation and data migration plans, IQ, OQ, PQ and summary reports. Other validation documentation as needed.
• Be able to author, update/revise SOP and other documents, as needed.
• Assisting with issues, bugs, and deviations adequate processing and documentation. Gather, understand and document business objective.
• Coordination of testing activities within the team, report progress of testing and significance of unfavorable results.
• Perform periodic compliance assessment to maintain data integrity at the site.
• Create, support and provide input into system administration and standard operating procedures (SOPs) to ensure adequate controls for maintaining the validated state.
• Coordinate and execute the training of Subject Matter Experts of electronic systems.
• Make recommendations for improvements in laboratory productivity and quality of data.
• Initiate and implement change control activities in accordance with current procedures.
• Work with MS&T leadership, IT leadership and business units to enhance existing procedures to further the efficiencies of compliance execution.
• Participate in quality and process improvement initiatives, and project teams.
• Contributes to the overall operations and to the achievements of department goals.
• Interact frequently with laboratory/manufacturing/IT/Quality facility staff to provide expertise on equipment/software validations. Address conditions/practices with appropriate personnel, reports findings to QA and Operations Management.
  
  

Qualifications:

• Bachelor’s degree in Science, Engineering, or related field, along with related business experience and a proven record of achievement.
• 5+ years of relevant experience in the pharmaceutical industry is required, including at least 5 years’ experience supporting compliant IT systems.
• Must be able speak to all levels of the organization regarding questions or concerns around compliance issues.
• Experience / Knowledge of 21 CFR Part 11, GAMP, CSV, and CSA.
• Knowledge of cGMP/GLP and 210, 211, 820 requirements.