Validation Engineer II
Intellectt INC
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.
Vacancy posted 1 day ago
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