CSV/CQV Validation Specialist – Onsite (Bend, OR)

Creative Solutions Services, LLC

Bend (OR)

On-site

USD 148,000 - 207,000

Full time

7 days ago

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Benefits offered by this job

Weekly Pay

Medical Insurance

Dental Insurance

Vision Insurance

Job summary

Creative Solutions Services, LLC is seeking a Validation Engineer 2 – CSV/CQV Specialist to support a high-priority backlog of qualification activities onsite in Bend, OR. This role emphasizes validation of analytical instruments, computerized systems, and GMP equipment, partnering with Instrumentation and CQV teams.

The ideal candidate has 3–5+ years of CSV/CQV experience in regulated settings, strong technical writing skills, and the ability to manage competing priorities while delivering

Qualifications

3–5+ years of CQV and/or CSV experience in regulated industries.
Experience validating analytical laboratory instruments and equipment.
Experience in a cGMP-regulated environment with computerized systems validation.

Responsibilities

Develop, execute, review, and maintain validation lifecycle documentation.
Support qualification of analytical instruments and GMP equipment.
Execute IQ/OQ/PQ activities and validation execution.
Ensure data integrity and compliance with 21 CFR Part 11 and EU Annex 11.
Collaborate with QC, Instrumentation, Engineering, QA on validation plans.
Utilize Kneat for document creation, routing, approvals, and closures.

Skills

CSV/CQV experience

Analytical lab exp

Technical writing

Project management

Cross-functional teamwork

Education

Bachelor's degree in Engineering/Life Sciences

Tools

Kneat

Job description

The ideal candidate has 3–5+ years of CSV/CQV experience in regulated settings, strong technical writing skills, and the ability to manage competing priorities while delivering

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