As a member of IT-CSV, the Senior CSV Engineer will participate in all phases of computerized system validation including the planning, writing, editing, assessment of regulatory risk and review of the following validation deliverables; project plans, validation plans, system requirements, test plans, test scripts, traceability matrix, exception reports, and summary reports. The Senior CSV Engineer will participate in the development, revision and maintenance of validation documentation such as the master validation plan, validation SOPs, and quality management systems designed to assist in the organization, planning, execution, monitoring, and reporting of validation activities.
Current pharmaceutical/medical device experience including risk-based approaches, industry best practices and application of guidance (e.g. GAMP 5) will be advantageous in this role.
Provide CSV guidance and direction for GxP validation efforts
Provide guidance on infrastructure verification activities
Participate in inspection readiness activities as it relates to CSV, backup/recovery planning and testing
Draft, Review and Approve CSV deliverables
Review and Provide feedback to current CSV processes and procedures
In depth knowledge of CSV within a regulated environment
Direct experience implementing CSV/SDLC programs and supporting processes
Great understanding of regulations including 21 CFR Part 11, EU GMP, GAMP 5, and Annex 11.
Extensive experience in managing multiple validation projects, developing plans, managing to project schedules and directing vendor/contract resources in creating CSV deliverables.
Diverse experience validating IT solutions for quality management, regulatory submissions, controlled document management solutions and clinical development
Experience maintaining a qualified infrastructure environment, change control best practices, configuration management
Must possess excellent communication, conflict resolutions, influence and problem-solving skills.
Deep understanding of the validation methodologies (GAMP 5, waterfall, etc) applied to on-site systems and hosted environments (SaaS).
Strong attention to detail, quality oriented
Must be self-motivated and comfortable in a fast-paced, demanding and dynamic work environment.
Bachelor’s degree in computer science or related field with 7 years of relevant experience.
"This posting is for Contingent Worker, not an FTE"