Senior QA Validation Engineer
Bend, OR
Category: Validation
Industry: Life Sciences
Standard Hours: Open
Reference ID: JN -092026-108644
Date Posted: 09/16/2026
Shortcut: http://careers.eliassen.com/7Ev79h
Description:
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. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance.
Rate: $75.00 to $90.00/hr. w2
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.
Experience 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.
Skills, experience, and other compensable factors will be considered when determining pay rate. The pay range provided in this posting reflects a W2 hourly rate; other employment options may be available that may result in pay outside of the provided range.
W2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), dental, vision, pre-tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick time if required by law in the worked-in state/locality.
If anyone reaches out to you about an open position connected with Eliassen Group, please ensure that you are working directly with us by confirming the following:
· When you work with Eliassen Group, all email communication will come from an Eliassen.com address, never Gmail, Yahoo, etc.
· Eliassen Group will never ask you for personal information (home address, bank account, or check routing number) until you have worked with someone clearly associated with Eliassen Group.
If you have any indication of fraudulent activity, please contact fraud@eliassen.com.
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Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. Eliassen Group’s Affirmative Action Plan (AAP) is available for inspection by any employee or applicant for employment upon request, during normal business hours of Monday through Friday, 8:30am to 5:30pm EST. Interested persons should contact Phaedra Wells at pwells@eliassen.com for assistance. It is unlawful in Massachusetts and Maryland to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Applicants with disabilities that believe they require an accommodation or assistance with a position, please email our HR team at hradmin@eliassen.com. This email inbox is designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Emails sent for other purposes will not receive a response.
Please be advised that a number of fraudulent job postings have been released under the Eliassen Group brand.
Unfortunately, fraudulent job postings can happen. If anyone reaches out to you about an open position connected with Eliassen Group, never provide personal or financial information to anyone who is not clearly associated with Eliassen Group
If anyone seemingly from Eliassen Group has ever requested this personal information in the past or does so in the future, please contact fraud@eliassen.com.
Please ensure that you are working directly with us by confirming the following:
- When you work with Eliassen Group, all email communication will come from an Eliassen.com address, never Gmail, Yahoo, etc.
- Eliassen Group will never ask you for personal information (home address, bank account, or check routing number) until you have worked with someone clearly associated with Eliassen Group, as indicated above