Primary responsibility is to provide/lead validation services required for the successful delivery of IT & Automation projects.
Provide validation & technical support through the preparation, execution, data analysis, & report writing for IV, OV & PV protocols.
Ownership of Change Requests (CR’s) related to project validation responsibilities.
Perform compliance & technical reviews/approvals of protocols & protocol data.
Author project quality masterplans (PQMP’s), validation plans (VPL’s), & other key validation documentation.
Author & execute assigned IV, OV & PV protocols for direct impact systems/processes per approved timeframes. Requires no guidance & direction to complete these goals & needs no coaching on technical competencies for goal obtainment. Serves as a source of expertise in the group for validating new systems.
Ensure compliance of validation protocols executed are aligned with local, corporate & regulatory regulations.
Lead validation failure investigations & non-conformities utilizing root cause analysis techniques.
Create & modify existing validation procedures & configuration item lists (CIL’s) as required.
Write/Review specifications, procedures, & other required supporting documents to maintain the validated state of equipment & processes.
Participate in FAT, SAT commissioning efforts for equipment, automation systems & processes & successfully transition into the ownership role for validation efforts related to the equipment.
Identify process improvements before equipment, systems or processes are placed under change control during validation.
Budget oversight as needed.
Contractor scheduling & oversight as needed.
Leads validation activities assigned by overall project manager.
Other accountabilities, as assigned.