Performs reviews and assessments on legacy equipment and processes against current Client and Industry Standards. The Validation Engineer will be responsible for identifying deficiencies or gaps in the validation lifecycle, developing remediation plans to remediate the process and equipment validation, and ensuring that all remediation activities are completed as scheduled in the remediation schedule.
Skills: Perform Comprehensive Reviews of Legacy Processes and Equipment:
Develop review/assessment schedule and ensure all activities are completed as scheduled.
Execute the Validation review section of the CPAT protocol.
Report the results of the CPAT execution in accordance with the instructions in the protocol and present the results to local management
Coordinate with process subject matter experts and the site Validation Lead to develop plans to remediate any deficient process and equipment validations to meet current standards, including a schedule of activities and their due dates.
Complete the remediation activities as scheduled.
.
Education:Bachelor degree in Engineering/ Physics or related discipline
2-5 years’ experience in medical device/pharmaceutical/biomedical process and equipment validation/qualification, in a regulated manufacturing facility.
.
Attachments: •
Last updated on Aug 11, 2016