Senior QA Validation Engineer

About the role

On-site in Bend, OR Our client seeks a Senior QA Validation Engineer to serve as the QA Validation SME and drive consistency in validation approaches across equipment, CSV, and facility/utility systems. The role requires GMP Quality Assurance experience within pharma or biotech, strong equipment and CSV validation background, and working knowledge of GxPs and applicable regulations. Method validation experience is a plus. Due to client requirements, applicants must be willing and able to work on a w2 basis.

Responsibilities

• Serve as SME and ensure consistency in validation approaches and requirements across site projects for equipment, CSV, and facility/utility systems.
• Collaborate across functions as the QA Validation SME and review/approve CQ, CSV, and method validation plans, protocols, and associated reports.
• Review and approve system lifecycle documents, vendor documentation, and periodic review reports.
• Support CQV and CSV projects. Method validation background is a plus.
• Perform change controls, risk assessments, and gap analyses on current validations and guide area owners with remediation as necessary.
• Participate in and support client and regulatory inspections as the QA Validation SME.
• Support review and approval of quality investigations, root cause analyses, and CAPA/EC actions through the site QMS.
• Implement data integrity requirements as part of project oversight.
• Support internal audits and external audit response writing as the QA Validation SME.
• Work with stakeholders to reduce potential data integrity risk from audit or inspection findings and perform gap assessments to ensure systems remain in a validated state.

Requirements

• Minimum 5 to 6 years of GMP experience with a Quality Assurance background in pharma or biotech.
• Strong background in equipment and CSV validation.
• Method validation experience is a plus.
• Working knowledge of GxPs and applicable regulations, including 21 CFR Part 11, Annex 11, and industry standards such as USP.

Benefits

• Medical, Dental, and Vision benefits
• 401k with company matching
• Life insurance

Pay

$75.00 to $90.00/hr. w2