Validation Specialist (CSV / CQV)

Randstad USA; Bend (OR); On-site; USD 131,000 - 142,000; Part time

Job summary

Randstad USA in Bend, Oregon is seeking a Validation Engineer 2 for a contract role to support CQV and CSV for analytical instruments, cGMP equipment, and computerized systems on-site. You will work to resolve backlogs and ensure regulatory compliance including 21 CFR Part 11 and EU Annex 11.

The role requires 3-5+ years of CQV/CSV experience, a Bachelor's degree, and the ability to work on-site in Bend with potential campus-wide travel. Kneat experience is preferred.

Qualifications

• 3-5+ years of CQV/CSV experience in a cGMP environment.
• Hands-on qualification and computer system validation for analytical lab instruments and cGMP equipment.
• Familiarity with 21 CFR Part 11, EU Annex 11, data integrity, and GxP requirements.
• Experience using Kneat for document creation, workflow routing, and approvals.
• On-site work requirement in Bend, OR and ability to travel between campus buildings.

Responsibilities

• Develop, execute, and review complete validation lifecycle documentation (URS, IQ/OQ/PQ, Risk Assessments, and Summary Reports).
• Perform qualification and CSV for analytical instruments and cGMP equipment.
• Ensure compliance with 21 CFR Part 11, EU Annex 11, data integrity, and GxP standards.
• Utilize Kneat platform for documentation workflows and approvals.
• Collaborate with QA, QC, and Instrumentation teams to manage change controls, deviations, and CAPAs.
• Conduct field execution, resolve discrepancies, and maintain inspection-ready docs.

Skills

CQV experience

CSV experience

Attention to detail

Education

Bachelor's degree

Tools

Kneat

Job description

Job Summary

Propel your career in scenic Bend, OR! A Top-Tier Global Pharma Leader is seeking a dedicated Validation Engineer 2 to join an innovative on-site team. In this high-impact contract role, you will tackle high-priority CQV and CSV backlogs, providing vital validation support for analytical laboratory instruments, computerized systems, and cGMP equipment.

Location: Bend, Oregon

Job Type: Contract

Salary: $98.00 - 100.72 per hour

Work Hours: 9 to 5

Education: Bachelors

Responsibilities

• Develop, execute, and review complete validation lifecycle documentation (URS, IQ/OQ/PQ protocols, Risk Assessments, and Summary Reports).
• Perform hands-on qualification and computer system validation for analytical laboratory instruments and cGMP equipment.
• Ensure strict adherence to 21 CFR Part 11, EU Annex 11, data integrity, and GxP regulatory requirements.
• Utilize the Kneat electronic validation platform for document creation, workflow routing, and digital approvals.
• Partner cross-functionally with QA, QC, and Instrumentation teams to manage change controls, deviations, and CAPAs.
• Perform field execution, resolve discrepancies, and maintain inspection-ready documentation.

Qualifications

• 3-5+ years of CQV and CSV experience in a pharmaceutical or biotechnology cGMP environment.
• Proven hands-on experience qualifying analytical laboratory instruments and computerized systems.
• Direct working experience using the Kneat validation software platform.
• Strong knowledge of GxP, 21 CFR Part 11, EU Annex 11, and USP/ASTM standards.
• Ability to work full-time on-site in Bend, OR and travel between campus buildings.

Skills: Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [e-mail].

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc.

• medical
• prescription
• dental
• vision
• AD&D
• life insurance offerings
• short-term disability
• 401K plan

(all benefits are based on eligibility).

This posting is open for thirty (30) days.