Senior QA Validation Engineer

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.

Recruitment Transparency Notice

Eliassen Group values transparency in our recruitment practices. Please be advised that Eliassen Group utilizes artificial intelligence (AI) tools as part of its initial application screening and hiring process. You may receive email and SMS notifications from the Eliassen Virtual Recruiting Team (, ) inviting you to complete a brief voice screening as part of your application process. These tools assist our hiring teams in different ways, including but not limited to, assistance in reviewing application materials to help identify candidates whose qualifications most closely match the requirements of the position. All AI-assisted evaluations and responses are reviewed by human recruiters before any hiring decisions are made. The use of AI in our process is intended to support fairness, efficiency, and consistency, and Eliassen Group takes measures to prevent bias or discrimination in connection with its hiring practices. By proceeding, you acknowledge, agree, and consent to Eliassen Group's use of these tools, including AI tools, as part of the application and hiring process.
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.
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About Eliassen Group:
Eliassen Group is a strategic consulting firm that helps organizations reach further and achieve more through our technology, business advisory, and life sciences solutions. For nearly 40 years, we have combined exceptional people, deep domain expertise, and intelligent capabilities to expand our clients' capacity and accelerate meaningful outcomes. We are driven by a purpose to positively impact the lives of our employees, clients, consultants, and the communities we serve.
Eliassen is committed to building a diverse and inclusive team from a variety of backgrounds, perspectives, and skills. We are an Equal Opportunity and Affirmative Action Employer and all employment decisions are based on merit, performance, and business needs. Eliassen does not discriminate on the basis of race, color, gender identity or expression, sexual preference or orientation, sex (including pregnancy, childbirth, and related medical conditions), marital status, creed, religion, physical or mental disability, genetic information, military or veteran status, age, ancestry, national origin, citizenship status, prohibited criminal record inquiries of applicants and employees, or any other category protected by federal, state, or local laws.
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