Csv Engineer

Pharma-Bio Serv, a global consulting firm headquartered in Puerto Rico, has been dedicated exclusively to providing services to the largest biotechnology & bio-engineering companies within the regulated industry for 30 years. Since our inception, our services have resulted in a project experience level and personnel resource base ranking among the highest worldwide.

Currently, we are gathering a pool talent for future CSV opportunity to provide services remote.

Duties may include:

• Previous experience working with Commissioning, qualification, and validation (CQV).
• Develop, update, review, approve and maintain qualification test protocols (IQ, OQ and PQ) and data migration protocols.
• Develop, update, review, approve and maintain summary reports and requirement traceability matrix.
• Review planned and unplanned changes (configuration updates, system enhancements, operating system updates, application updates, etc.) and assess validation impact.
• Perform risk assessment of proposed changes to determine scope of validation/re-validation.
• Other duties related.

Requirements:

• Bachelor’s Degree in Science or related.
• 3-5 years CSV &/or CQV experience within a regulated (pharmaceutical/medical device industry) environment.
• Preferably with Veeva and TrackWise validation experience with relevant 21 CFR Part 11 & 211, ICH E6(R2) & ICH Q9.
• Demonstrated experience and excellent knowledge of applicable CSV and other applicable regulations GMP guidance.

Send your resume today!