Enterprise Quality Computer System Validation Engineer
About the Job
The Enterprise RA/QA group is seeking a result-oriented Computer System Validation Engineer, with experience preferred in implementation and validation of SAP, SAP SuccessFactors and Oracle's Agile. In this role, you will be involved in various phases of CSV Lifecycle from Planning, requirement gathering, Part -11 and risk assessments, Test protocol, Test execution, and validation report.
You will work closely with Agilent's business team, division quality and IT to plan, implement and maintain the validation for GxP Systems, as well as, other applications and processes across Agilent. This includes the development of new systems, modules or processes within these applications, as well as maintenance / change control and data migration activities.
- Develop validation plans, data migration plans, qualifications and associated reports to demonstrate that the Agilent computerized systems meet intended use and comply with regulatory requirements.
- Review and provide comments on submitted CSV deliverables, ensure validation efforts are executed to plan and properly documented in the appropriate validation documents, they are complete, accurate, authored per established standard operating procedures and adequate for the intended use and in alignment with applicable FDA/EU and ISO regulations.
- Gather and document user requirements as needed from business stakeholders to establish intended use of computerized systems.
- Ensure validated systems remain in compliance with industry standards as changes to applications are made, including the re-qualification of applications or processes as needed.
- Maintain computerized system validation documentation and provides support for FDA inspections, notified body audit, and internal and external audits in respect to system validation.
- Maintain validation procedures and review and approve changes to existing IT QMS processes and technical procedures.
- Review and approve IT Software system validations and changes. Participate in the Agile Change Control Board.
- Participating in the Quality Training Program -- developing and improving training material, conducting relevant training of new and existing employees.
- BS degree in Computer Science, IT, Biomedical, Pharmaceuticals, Chemical or any other variety of engineering with years of experience in Information Technology and computer system Compliance and/or Validation; or equivalent combination of education and experience.
- 5+ years of relevant experience Assurance in medical devices and/or pharmaceutical industry. (In Vitro Diagnostic experience a plus)
- Hands on validation experience within regulated environment required, including authoring Validation Plans and Reports.
- Profound knowledge of medical device/IVD regulations such as FDA CFR 21 Part 820 and Part 11, ISO13485, 14969, ISO 14971 and IVD/Medical Devices regulations in EU and USA
- GxP experience in Pharma or Med Devices with Quality Management System (QMS) records (e.g. Deviations, CAPAs, Change Management)
- Prefer knowledge on 21CFRPart 210/211 and data integrity
- Experience in validation and implementation of Oracle Agile specially in BOMs, product attributes, defining workflows, privileges/roles, user groups etc.
- Knowledge of initiating and creating new products and bill of materials in Agile, releasing them as ECOs to ERP system
- Knowledge and experience in validation and implementation of SAP and SAP SuccessFactors Learning
- Business and result oriented and a desire to work in a dynamic and adaptable environment.
- Good team player, work effectively with teams across different businesses, functions and geographies
- Demonstrated interpersonal and communication skills (oral, and written)