Validation Engineer II

Dawar Consulting•Hillsboro, OR

1d•$70 - $78

About The Position

Our client, a world leader in diagnostics and life sciences, is looking for a Validation Engineer II” based out of Hillsboro, OR. Job Duration: Long term Contract (Possibility Of Further Extension) Pay Rate: $70/hr - $78/hr on W2 Company Benefits: Medical, Dental, Vision, Paid Sick leave, 401K Active involvement in the daily operations for all Manufacturing ITOT systems and infrastructure to support the system owners for all Manufacturing systems and supporting the team in manufacturing site projects and with various administrative tasks and validation activities.

Requirements

Good knowledge of Food and Drug Administration regulations/guidance (or Annex)

Responsibilities

Be responsible for the review of system documentation according to the client's CSV SOPs and regulatory guidance.
Develop plans and reports such as validation plans/reports, test plans/reports (and other deliverables). Update existing validation deliverables and procedures in collaboration with the system owners.
Apply ALCOA+ principles to validation deliverables and quality management system records.
Support in deviation investigations to identify causes and define corrective and/or preventative actions.
Support system maintenance and enhancement activities, ensuring the validated state is kept, and it is audit and inspection ready.
Collaborate with local and global stakeholders in defining and completing validation and compliance activities.