About this opportunity
Creative Solutions Services, LLC lists this Validation Engineer 2 opportunity in bend, Oregon. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Validation Engineer 2 – CSV/CQV Specialist
Location: 1201 NW Wall Street, Bend, OR 97703
Work Model: Full-Time, Onsite
Contract Duration: 6–9 Months (Potential for Extension or Full-Time Conversion)
Pay Rate: $70.92–$99.29/hour (W2)
Benefits: Weekly Pay, Medical, Dental, and Vision Insurance
Position Overview
Our client is seeking a Contractor-level CSV/CQV Specialist to support a high-priority backlog of qualification and validation activities within the CQV organization. This role will focus on the validation of analytical laboratory instruments, computerized systems, and GMP equipment while partnering closely with the Instrumentation and CQV teams .
The ideal candidate will have strong CSV and CQV experience , preferably within an analytical laboratory or pharmaceutical/biotechnology environment. This position requires someone who can effectively manage competing priorities, produce high-quality validation documentation, and participate in hands‑on qualification and field execution activities.
Onsite presence in Bend, Oregon is required.
Hiring Manager Priorities
Immediate need due to a significant CQV validation backlog .
Strong preference for candidates with analytical laboratory experience .
Candidates with both CSV and CQV experience are highly preferred.
Must be comfortable balancing priorities between CQV and Instrumentation teams .
Must be willing to work onsite in Bend to support instrument qualification and field execution activities.
Previous experience with backlog remediation or high-volume validation activities is highly desirable.
Key Responsibilities
Develop, execute, review, and maintain validation lifecycle documentation, including: Risk Assessments
User Requirements Specifications (URS)
Design Specifications
Traceability Matrices
Test Scripts
Validation Protocols
Discrepancies and Deviations
Summary Reports
Periodic Review Documentation
System Retirement Documentation
Support qualification and validation activities for new and existing analytical laboratory instruments, computerized systems, and GMP equipment.
Execute and support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.
Ensure calibration readiness, data integrity verification, and compliance with 21 CFR Part 11 and EU Annex 11 requirements.
Partner with Quality Control, Instrumentation, Engineering, Automation, Quality Assurance, and system owners to plan and execute validation activities.
Prepare and support change controls, impact assessments, deviations, CAPAs, and validation protocols related to GMP equipment, analytical instruments, and computerized systems.
Utilize the Kneat validation platform for document creation, workflow routing, approvals, and record closure.
Assist with Kneat template development and continuous improvement initiatives.
Maintain inspection‑ready documentation in accordance with SOPs, GxP requirements, and site procedures.
Monitor field execution activities, identify gaps, drive discrepancy resolution, and elevate issues as needed.
Provide support to the Instrumentation team for CSV activities and the CQV team for qualification execution, documentation updates, and readiness activities.
Travel between Bend campus buildings as needed to support laboratory instrument and equipment qualification.
Perform other duties as assigned.
Required Qualifications
Education
Bachelor’s degree in Engineering, Life Sciences, Chemistry, Biology, or a related scientific discipline preferred.
Experience
3–5+ years of CQV and/or CSV experience within pharmaceutical, biotechnology, medical device, or another regulated industry.
Experience supporting qualification of analytical laboratory instruments and equipment .
Experience working in a cGMP-regulated environment .
Experience with computerized systems validation and equipment qualification.
Experience managing multiple validation projects and competing priorities.
Experience supporting validation backlogs or high-volume validation activities is highly desirable.
Technical Knowledge
Hands‑on experience with Kneat validation/documentation software .
Strong understanding of GMP documentation requirements and validation practices.
Knowledge of: GxP regulations
21 CFR Part 11
21 CFR Parts 210 and 211
EU Annex 11
Annex 15
USP and ASTM standards
Understanding of computerized systems, laboratory instruments, pharmaceutical manufacturing equipment, specifications, procedures, and engineering drawings.
Strong understanding of the differences between equipment qualification and instrument/computerized system validation .
Key Competencies
Excellent technical writing and documentation skills.
Strong organizational skills and attention to detail.
Ability to prioritize multiple projects and stakeholder requirements.
Strong analytical and problem‑solving skills.
Ability to work independently and collaboratively in a regulated environment.
Strong communication and cross‑functional collaboration skills.
Commitment to quality, compliance, and data integrity.
Ability to work effectively in a fast‑paced environment with a significant validation backlog.
Physical & Environmental Requirements
Work within a clean, secure, and regulated GMP environment.
Follow all required site safety procedures and wear appropriate PPE, including lab coats, safety glasses, gloves, and other protective equipment as required.
Ability to occasionally lift up to 50 pounds .
Ability to travel between site buildings as needed.
Flexibility to support project and field execution activities.
Ideal Candidate Profile
The strongest candidate will be an experienced CSV/CQV professional with analytical laboratory instrument qualification experience , strong GMP documentation skills, and hands‑on experience executing IQ/OQ/PQ activities. Candidates who have worked with Kneat , supported validation backlogs, and can effectively balance CSV responsibilities with CQV execution will be highly competitive.
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Worksite address
bend, OR, 97707, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.