CSV Engineer
Responsibilities:
- Creates Computer System Validation (CSV) deliverables (Validation Plan, Requirements Specifications, Protocols, Summary Reports, Trace Matrices, SOPs, Risk assessments).
- Collaborates with Business Users, System Owner, Global IT teams and Business Analysts to define validation requirements and plans.
- Providing leadership, oversight, and training related to validation activities to multi-functional teams.
- Generate and execute validation protocols (IQ/OQ/PQ) using Good Documentation Practices (GDP).
- Ensuring that the quality system elements necessary to achieve and maintain compliance across multiple businesses, including regulated environments, are established and activities related to computer systems/software testing are controlled via these elements.
- Working with appropriate teams to establish quality expectations related to validation planning and execution.
- Participating with stakeholders in the preparation of software specification documents, risk management and validation plans.
- Participating in developing qualification processes and implementing standard operating procedures.
- Participate in execution of gap assessment and remediation activities.
- Investigate and resolve exceptions, non-conformances, deviations, CAPAs and change controls related to validation protocols.
- Authoring, reviewing, and/or approving system change, configuration management and supporting documentation activities.
- Preparing for and participating in external/internal computer system/software audits.
- Serve as the SME for CSV activities and maintain knowledge and information in the CSV area of expertise.
- Contributing to process improvements by developing and updating written procedures related to computer systems.
- At least 8-10 years of experience in Computer System Validation in the pharmaceutical, biotech, medical device, or other regulated industry.
- Demonstrated experience in software quality assurance processes, SDLC methodology, change management, documentation, verification, and validation techniques.
- Understanding of GAMP 5 techniques and software industry standards and their impact on internal procedures, and software quality.
- Demonstrated project management and leadership skills.
- Proficiency in interacting with contacts, including project teams and vendors.
- Certified auditor or equivalent experience conducting software-vendor quality audits.
- Working knowledge of the FDA Quality System Regulation, 21 CFR Part 11, EU GMP, Annex 11 and the European and Canadian Medical Device Directives.
- Understanding of current software quality techniques and industry standards such as ISO, ASQ, AAMI, and GAMP
- Experience with the following software systems/applications:
- Quality Management System
- Document Management System
- Validation Management System
- Bachelor's/Master's degree in Computer Science Engineering or equivalent.
