CSV Quality Engineer

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Required Skills & Experience

• Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field.
• 5+ years of experience in CSV and software assurance within the medical device, pharmaceutical, or biotech industry.
• Strong understanding of :

o 21 CFR Part 11, Part 820, ISO 13485, ISO 14971

o GAMP5 guidelines, FDA guidance on risk-based software validation and computer software assurance

• Proven Experience with software development lifecycle (SDLC) and Computer System Validation (CSV) documentation.
• Experience with equipment and software development, validation and deployment activities for Manufacturing and Laboratory equipment.
• Experience with validation and compliance of on-premises and cloud-based (SaaS) applications
• Experience with QMS software platforms (i.e. MasterControl, Veeva, TrackWise).
• Experience with ERP platforms (i.e. SAP, QAD) and other enterprise business applications supporting GxP processes
• Detail-oriented with strong communication, technical writing and audit readiness skills.
• Ability to simultaneously manage multiple, cross-functional, validation projects

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and / or other paid time off as provided by applicable law.