Computer System Validation Consultant

Job DescriptionJob DescriptionPharma-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 over 30 years. Since our inception, our services have resulted in project experience level and personnel resource base ranking among the highest worldwide.Currently, one of our clients in the Medical Device sector is looking to hire a Computer System Validation (CSV) Consultant position in Jacksonville, Florida.Job Description and Qualification: 5 -10+ years of Computer systems validation (CSV) experience in computerized equipment within manufacturing systems.Author, review and approve GxP computer system lifecycle documentation such as URS, FRS, CS/DS, risk assessments, validation plan, test protocol, summary reports and RTM.Development of Periodic Review assessments, including gathering required data, evaluation of data and write and approve the periodic review report.Develop and execute test protocols and test scripts (IQ/OQ/PQ) for computerized systems.Knowledge of regulatory requirements and standard best practices, (e.g. GLP/GMP, 21 CFR Part 11, Annex 11, GAMP5) with respect to computerized systems and data integrity.Write and provide support for all CSV related deviations, discrepancies and change control documentation.Proficient in technical writing skills. This position does not offer visa sponsorship.Company DescriptionPharma-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 more than 30 years. Since our inception, our services have resulted in a project experience level and personnel resource base ranking among the highest worldwide.Company DescriptionPharma-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 more than 30 years. Since our inception, our services have resulted in a project experience level and personnel resource base ranking among the highest worldwide.

Created: 2026-03-04