Validation Engineer II

Job Title: Validation Engineer II
Location: Bend, OR
Employment Type: Contract W2
Duration: 6+ Months
Rate: $46 - $50/hr W2
Work Arrangement: Onsite

About the Role
We are seeking a Validation Engineer II / CSV-CQV Specialist to support qualification and validation activities within a regulated cGMP environment. The role will focus on analytical laboratory instruments, computerized systems, and GMP equipment while supporting both CQV and Instrumentation teams.

Responsibilities

• Execute CQV and CSV activities for analytical laboratory instruments, computerized systems, and GMP equipment.
• Develop, review, and execute validation protocols, reports, and supporting documentation.
• Support IQ/OQ/PQ, instrument qualification, equipment qualification, and validation backlog remediation.
• Partner with Instrumentation, CQV, Quality, and other cross-functional teams to manage priorities and resolve validation issues.
• Maintain compliance with cGMP requirements, data integrity expectations, and applicable validation procedures.
• Manage multiple validation activities and competing priorities while meeting project timelines.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, Chemistry, Biology, or a related technical/scientific field preferred.
• 3 5 years of CQV and/or CSV experience in pharmaceutical, biotechnology, or other regulated industries.
• Hands-on experience with analytical laboratory instruments and equipment qualification.
• Experience with Computerized Systems Validation and equipment qualification.
• Knowledge of cGMP requirements and validation documentation practices.
• Strong organizational, communication, troubleshooting, and project management skills.

Preferred Qualifications

• Experience with both CSV and CQV activities.
• Experience supporting validation backlog remediation or high-volume validation projects.
• Analytical laboratory experience.
• Experience working closely with Instrumentation teams.