Back to jobsProvide 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
