Responsible for performing the validation of equipment, utility systems, facilities, processes and/or automation systems for projects. This includes developing validation master plans with minimum supervision, preparing protocols independently, analyzing test results, and preparing technical reports.
Contributes directly to the completion of validation projects through the development of validation schedules, master plans, validation protocols and reports for systems that may be complex in nature, to support clinical and commercial manufacturing.
Coordinates validation activities with, and seeks team supports from, Validation, Development, Manufacturing, Engineering, Quality, third Parties, and other groups on validation projects to ensure validation projects are carried out on time and on budget.
Coordinates the activities of assigned validation and contract personnel and ensures the quality of completed work.
Reviews protocols, reports and data tables generated by peers and contract personnel.
Represents the department on cross-functional project teams.
As required, assists in preparation of regulatory submissions and presents validations in respective SME areas to regulatory authorities during routine internal and pre-approval inspections.
**Possible weekend / Holiday work may be required due to department workload. Schedule must be flexible to accommodate off-shift work.**