Pharma-Bio Serv PR, Inc.
Added - 05/25/22 CSV Engineer Engineering Boston , Massachusetts |
Pharma-Bio Serv PR, Inc., Boston, Massachusetts, us, 02298
Added - 05/25/22CSV EngineerEngineeringBoston, Massachusetts | ContractJob Overview
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.Specific Duties Include:
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.Requirements:
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.
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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.Specific Duties Include:
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.Requirements:
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.
#J-18808-Ljbffr