CSV Engineer

2 weeks ago

Boston, United States Trinity Consultants - Advent Engineering Life Science Solutions Full time

CSV Engineer


This is a hybrid role in the Boston area. Only candidates with Biopharmaceutical experience will be contacted.


ADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Headquartered near San Francisco, California, and with operations in the Eastern and Western US, Canada and Singapore, our company is involved in almost every facet of global pharmaceutical and biotechnology facility design and process engineering and quality system projects.



ADVENT's services include process engineering, automation engineering, project engineering, HVAC/facility system design, process development, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.


This is an outstanding opportunity to join our growing team



Position Description

The Computer Systems Validation (CSV) Engineer will perform validation activities in support of GMP computerized systems. Examples include EDMS, Trackwise, LIMS, and automated manufacturing systems. The position requires development and/or execution of requirements specifications, configuration specifications, Installation Qualification (IQ) protocols, Operational Qualification (OQ) protocols, Performance Qualification (PQ) protocols including collaboration, oversight, test execution, discrepancy/deviation management, and generating final reports. The job also requires representing validation interests on project teams, interacting with vendors, contractors, overseeing preparation of validation change control request records, and conducting periodic reviews.


Position Requirements

  • BS in a Computer Science or Engineering field or equivalent experience
  • 5-15 years’ experience with Computer systems validation, including experience in authoring/reviewing/approving validation documentation (URS, Risk Assessment, IQ/OQ/PQ)
  • Strong background and understanding of FDA regulations
  • Deep 21CFR Part 11 experience is preferred
  • Knowledge and experience with GAMP5 Risk Based Approach to GxP Computerized Systems and risk assessment method is preferred
  • Provide inputs supporting creation of computer system related policies, procedures, templates, forms, etc.
  • Review/assess computer system change controls, discrepancies, CAPAs
  • Review and provide feedback to vendor validation documentations (validation plans, executed protocols, risk assessments, etc.)
  • Works closely with the QA function to provide expertise in CSV compliance, manage identified issues, and support continuous improvement
  • Support inspection readiness programs and/or directly support regulatory agency inspections. Assist in the coordination of response to any findings as applicable.
  • Develop and evaluate quality processes and system standards to ensure compliance with applicable procedures, industry standards and global regulations.
  • Experience with validation and operation of the following preferred: TrackWise, LabWare LIMS, Software as a Service (SaaS), DocuSign, PLC, automated manufacturing systems.

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