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 more than 29 years. Since our inception, our services have resulted in a project experience level and personnel resource base ranking among the highest worldwide.

Currently, one of our clients is looking to hire a CSV Engineer employee to provide services at Massachusetts, USA. This is an on-site opportunity. 

• Develop, update, review, approve and maintain qualification test protocols (IQ, OQ and PQ) and data migration protocols.
• Work with internal and external IT teams, business owners and system owners to develop requirements specifications (URS, FRS and SDS) for GxP systems used by IMGN.
• Develop and maintain Master Validation Plan (MVP) and Validation Plan (including data migration plan) for E-systems.
• 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.
• Own change control tasks related to system validation and execute them in timely manner.
• Coordinate and/or perform test execution of qualification test protocols as necessary.
• Work with technical and business teams to troubleshoot technical issues encountered during test execution and/or during daily operation of the system.
• Develop, maintain, and execute E-system periodic review plan to ensure validated electronic systems remain in compliance with appropriate IT and Quality procedures (change control, backup & recovery access control).
• Participate in the continuous improvements of CVS policies and procedures by providing independent review of the existing documentation.
• Help select/manage applicable vendors to ensure completion of deliverables identified in the vendor contract/SOW.
• Participate in vendor audits to ensure system used by Clients GxP vendors meet FDA regulation and industry validation standards.
• Serve as a backup system administrator (user, report, and configuration management) for selected computer systems.

• Bachelor’s Degree in life sciences, engineering, or IT/Computer Science
• 3-5 years’ experience in a regulated (pharmaceutical/medical device industry) environment with expertise in the IT System Development Lifecycle.
• Ideal candidate brings Veeva and TrackWise validation experience with relevant 21 CFR Part 11 & 211, ICH E6(R2) & ICH Q9, and EudraLex Annex-11 experience.
• Demonstrated experience and excellent knowledge of applicable CSV and other applicable regulations GAMP guidance.