CSV Specialist
On-siteGurabo, Gurabo, Puerto Rico
Job Summary
Develop, review, and execute CSV deliverables including Validation Plans, Risk Assessments, URS, FRS, IQ/OQ/PQ protocols, and Validation Summary Reports. Ensure computerized systems meet data integrity and regulatory compliance requirements for FDA, cGMP, 21 CFR Part 11, and GAMP 5. Support system implementations, migrations, upgrades, and periodic reviews across manufacturing and quality systems, collaborating with IT, QA, and Manufacturing teams. Participate in impact assessments, change control activities, and deviation resolution. Provide technical and compliance support during internal and external audits while maintaining documentation aligned with corporate quality systems. Promote continuous improvement of CSV practices across site operations.
Required Qualifications
- Bachelor's Degree in engineering
- Minimum of 5 years of hands-on experience in Computer System Validation within the pharmaceutical or biotechnology industry
- Strong knowledge of CSV lifecycle methodology, 21 CFR Part 11, Annex 11, and GAMP 5
Desired Qualifications
- Experience with parenteral operations or aseptic manufacturing environments preferred
- Excellent documentation, communication, and teamwork skills
- Fully bilingual (Spanish/English) preferred
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.