Senior Validation Engineer
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Job Location:
Boston, NH - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Job Summary (List Format):
- Support the Quality Information Systems Management group by collaborating with operational business and QA teams.
- Facilitate regulatory assessments change control reviews requirements gathering system design and system testing.
- Provide quality oversight and assume quality ownership for all computerized system projects.
- Ensure quality compliance and manage quality risks during project implementation and enhancements.
- Participate in cross-functional discussions offering quality guidance and decisions for system projects (including new implementations enhancements releases and reviews).
- Review and approve quality events (such as deviations and CAPAs) project deliverables test scripts and reports.
- Drive system assessments and the resolution of issues related to system quality and compliance.
- Communicate quality risks and mitigation plans to project teams while ensuring ongoing quality assurance throughout all stages of systems development and implementation.
- Leverage expertise in enterprise computerized systems (e.g. ServiceNow QMS ERP Veeva EDC Compass RIM data analytics lab and manufacturing systems).
- Utilize strong technical writing communication and project management skills to deliver innovative and compliant system solutions.
- Support the Quality Information Systems Management group by collaborating with operational business and QA teams.
- Facilitate regulatory assessments change control reviews requirements gathering system design and system testing.
- Provide quality oversight and assume quality ownership for all computerized system projects.
- Ensure quality compliance and manage quality risks during project implementation and enhancements.
- Participate in cross-functional discussions offering quality guidance and decisions for system projects (including new implementations enhancements releases and reviews).
- Review and approve quality events (such as deviations and CAPAs) project deliverables test scripts and reports.
- Drive system assessments and the resolution of issues related to system quality and compliance.
- Communicate quality risks and mitigation plans to project teams while ensuring ongoing quality assurance throughout all stages of systems development and implementation.
- Leverage expertise in enterprise computerized systems (e.g. ServiceNow QMS ERP Veeva EDC Compass RIM data analytics lab and manufacturing systems).
- Utilize strong technical writing communication and project management skills to deliver innovative and compliant system solutions.
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
