Piper Companies is seeking a CSV/Validation Engineer in Spokane, WA to support a global integrated pharmaceutical company offering a wide range of products and services to our customers across geographies.
Responsibilities for the CSV/Validation Engineer include:
- Create and manage validation lifecycle documentation including validation plans, user and functional requirements, technical and functional business process flows, risk assessments, IQ/OQ/PQ Test Scripts, traceability matrices, validation summary reports.
- Provide technical expertise to define approaches and execution of system validation activities in accordance with cGxP, CFR Parts 11, 210 & 211, Annex 11, and other applicable regulations or procedures.
- Create, review, and modify IT related SOPs Work with project teams to select methods and techniques for obtaining desirable solutions for each project and work with QA to ensure compliance with regulations.
- Conduct/ assist in computer systems compliance assessments.
- Work collaboratively to ensure the development of CSV best practices.
- Assist QA in perform Internal Audits.
- Assist QA and business owners with Periodic Reviews.
Qualifications for the CSV/Validation Engineer include:
- 3+ years experience writing validation documentation
- Test scripts, summary reports
- Managing IT related SOPs, Sops need to be re-written, review/approved
- Experience with IT harmonization across multiple sites
- Experience with FDA/GMP regulations
- B.S. in Comp Sci preferred
Compensation for the Validation Consultant include:
- $80,000-$90,000; relocation available
- Comprehensive benefits package
Please send all qualified resumes to Karen Pallone at firstname.lastname@example.org