Work closely with internally assigned departments and externally with software vendors and/or contractors, regulatory audit teams and other service providers to facilitate implementation, testing and application of validation principles throughout the implementation process. Demonstrate mid-level technical expertise to define approaches and execution of system validation activities in accordance with cGMP, cGXP, CFR 21 Parts, 11, 210 and 211, EU Annex 11, ICH Q7, Q8 and Q9, and other applicable regulations, procedures and industry guidance.