Senior QA Validation Engineer - GMP/CSV Expert, Bend, OR

Eliassen Group; Bend (OR); On-site; USD 103,000 - 124,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401k with company matching

Life insurance

Job summary

Eliassen Group is seeking a Senior QA Validation Engineer to serve as the QA Validation SME in Bend, OR. On-site role requiring GMP QA experience with equipment and CSV validation, with method validation as a plus. The position is a W2 contracting role offering a strong benefits package.

Responsibilities include ensuring validation consistency, reviewing validation plans and reports, supporting CQV/CSV projects, and contributing to inspections and data integrity across site systems.

Qualifications

• Minimum 5–6 years of GMP QA experience in pharma/biotech.
• Strong background in equipment and CSV validation; method validation is a plus.
• Working knowledge of GxPs and regulatory requirements (21 CFR Part 11, Annex 11, USP).

Responsibilities

• Serve as QA Validation SME and ensure consistency across equipment, CSV, and facility/utility validation.
• Review/approve CQV, CSV plans, protocols, and reports; collaborate across functions.
• Review system lifecycle documents, vendor docs, and periodic review reports.
• Support CQV/CSV projects; perform change controls, risk assessments, and gap analyses.
• Assist in client and regulatory inspections; support CAPA/EC actions and investigations.
• Implement data integrity requirements and assist audits and response writing.

Skills

QA Validation

GMP Experience

CSV Validation

GxP Knowledge

Regulatory Compliance

Job description

Eliassen Group is seeking a Senior QA Validation Engineer to serve as the QA Validation SME in Bend, OR. On-site role requiring GMP QA experience with equipment and CSV validation, with method validation as a plus. The position is a W2 contracting role offering a strong benefits package.

Responsibilities include ensuring validation consistency, reviewing validation plans and reports, supporting CQV/CSV projects, and contributing to inspections and data integrity across site systems.