Sr. Computer System Validation Consultant

Sr. Computer System Validation ConsultantLocation is Exton, PA, USAlong term aria-hidden="true" Job Summary aria-hidden="true" Working independently and with company personnel, the Senior Computer System Validation Consultant is responsible for the creation and review of user requirements documents, configuration specification, validation plans, test scripts, traceability matrices, summary reports and change controls, Part 11 assessment, as well as test script execution. aria-hidden="true" The consultant will be supporting validation efforts for stand-alone IT systems (e.g., Trackwise, LIMS, CMMS) and laboratory instrument software (e.g., OpenLab, SoftMax Pro, Gyrolab), but not manufacturing automation systems (e.g., DeltaV). aria-hidden="true" Knowledge/Skills/Abilities Required aria-hidden="true" Minimum of 5 years of computer system validation experience aria-hidden="true" Minimum 2 years of experience validating laboratory instrument software aria-hidden="true" Knowledge of 21 CFR Part 11, cGMP, GDP, and other regulatory requirements aria-hidden="true" Strong communication (verbal and written) and diplomacy skills aria-hidden="true" Ability to work collaboratively with personnel representing many different business areas aria-hidden="true" Willingness to lead some valuation projects independently, while also following the lead of more senior validation personnel for other validation projects aria-hidden="true" Willingness to work with vendors and vendor documentation to figure out how software can and should be configured to improve Part 11 compliance aria-hidden="true" aria-hidden="true" This is a hybrid role. aria-hidden="true" aria-hidden="true" Client requires all contractors providing services to Client to be fully vaccinated against COVID-19 and provide valid proof of vaccination as of their start date to their employer/supplier, to the extent permitted under applicable law. This requirement is a condition of providing services to Client, and it applies regardless of whether the contractor is located at an Client site, field based or is fully remote. If you are unable to receive the vaccine for qualified medical reasons (including pregnancy-related) or religious reasons (sincerely held religious beliefs), you will have an opportunity to request a reasonable accommodation from your employer/supplier.