CSV Validation Engineer

Qualifications

Education:

• Minimum of a Bachelor's degree in Computer Science, Information Systems, Business Administration, or an equivalent field required
• Cloud Practitioner certification preferred

Experience and Skills:

Required:

• Minimum 4 years of relevant work experience
• Experience in either Computer System Validation (CSV) activities and/or in Cloud computing supporting IAAS, PAAS & SAAS services
• Experience authoring or approving validation protocols, non-conformities, Change Requests, SOPs, and/or Validation Plans and Reports
• Experience working with Jira, Jenkins, Github, Bitbucket, Artifactory, Chef or equivalent Agile Development tools

Preferred:

• Detailed knowledge of GxP regulations related to CSV, including 21 CFR Part 11, Part 210, Part 211, and Part 820
• Experience in implementing regulatory requirements on Virtual Private Clouds (VPCx), Infrastructure as Code, and/or Containers services
• Working knowledge of Global Regulations such as EU Annex 11, SOX, HCC, Security & Privacy, and/or ISO
• Solid understanding and knowledge of DevSecOps, PMO, SDLC, GAMP 5, and/or ITIL frameworks
• Knowledge of one or more of the following technologies and methodologies: Agile, CICD, RPA, Cloud Storage and Computing, IoT, Data & Analytics, AI/ML, Intelligent Automation, Blockchain, Kubernetes, and/or SaMD
• Industry experience within Pharmaceutical, Medical Device, and/or Biotech

Key Responsibilities:

• Ensure that all quality standards and global regulatory requirements are being met
• Ensure that activities include early involvement of quality in the design and development activities, building quality into the work product, building controls within the application/solution, and using automation whenever feasible
• Promote the quality approach for systems and ensure teams are accountable for delivering on an end-to-end support model for systems in scope
• Provide technical and procedural expertise/mentorship to the project teams as well as aligning with both internal and external collaborators
• Plan, implement, and maintain the risk-based validation activities for GxP systems/applications
• Support internal audits and Health Authority regulatory inspections for supported systems
• Approve SDLC validation documentation including the approval to release system implementation and/or changes for production use, attend project team meetings, provide quality and compliance mentorship, support base business project activities
• Work with globally diverse teams in an inclusive environment
• Promote an environment which encourages the Company's Credo and the value of a diverse workforce