Job Title: Computer System Validation Managers (Multiple Openings) 

Job Description:

• Responsible for planning, executing, monitoring and reporting of activities for FDA regulatory compliance projects of GxP systems. 
• Perform Root Cause Analysis for deviations from process and agreed metrics. Perform risk management. 
• Responsible for review and approval of deliverables to make sure it complies with GxP and GDP principles of FDA and other regulatory bodies. 
• Facilitate and perform GMP assessments, risk assessments, manage validation services, and training of team members on GxP and GDP compliance. 
• Review Validation Plan, strategize and coordinate validation activities. 
• Review and provide recommendations for validation deliverables. 
• Work with MS Project (MPP), Computer System Validation (CSV), Computer Software Assurance (CSA), Micro Focus ALM, GAMP5, Oracle Agile PLM, TrackWise, Veeva Vault, ServiceNow, Share Point, 21 CFR Part 11, Annex 11, GxP, GDP, FRA, Risk Based Validation, Oracle and SAP Manufacturing & Supply Chain Applications. 40 hrs/wk. 
• Must have Bachelor’s Degree (3 or 4 year U.S. or foreign degree) in Computer Science, Electr Engineering, or a related field, and five (5) years of experience in the proffered position, or as a Project Manager, Validation Engineer, QA Tester, Sr. Associate-Projects, or related occupation. 
• Must have 2 years experience with planning, executing, monitoring and reporting of activities for FDA regulatory compliance projects of GxP systems; Performing Root Cause Analysis for deviations from process and agreed metrics; Performing risk management; Working with GxP, GAMP, GDP, 21 CFR Part 11, Annex 11, CSV, CSA, FRA, Risk Based Validation. 
• Must be willing to travel/relocate to unanticipated locations throughout the US on short notice for extended periods of time.