CSV Validation Specialist – Pharma & Regulated Systems

Creative Solutions Services, LLC; Denver (CO); On-site; USD 90,000 - 130,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a candidate with strong experience in pharmaceutical/biotech/medical device validation. The role emphasizes experience with System Development Life Cycle, Computer System Validation, and adherence to FDA/GxP standards.

The position involves leading validation efforts, coordinating documentation, and collaborating with QA and cross-functional teams. Ideal candidates will have hands-on experience writing validation deliverables, reviewing test scripts,

Qualifications

• Experience in the pharmaceutical, biotechnology, or medical device industry.
• Experience in writing and executing documentation for validation deliverables (requirements, validation plans, test protocols, test summaries, validation reports).
• Experience in QA methodologies, reviewing and approving test plans, UAT scripts and test procedures.
• Experience with FDA guidance and industry standards (GAMP).

Skills

Regulatory experience

GxP knowledge

Documentation proficiency

QA methodologies

Job description

Creative Solutions Services, LLC is seeking a candidate with strong experience in pharmaceutical/biotech/medical device validation. The role emphasizes experience with System Development Life Cycle, Computer System Validation, and adherence to FDA/GxP standards.

The position involves leading validation efforts, coordinating documentation, and collaborating with QA and cross-functional teams. Ideal candidates will have hands-on experience writing validation deliverables, reviewing test scripts,