VWR International, Inc. Computer System Validation Engineer in Radnor, Pennsylvania

The Computer System Validation Engineer will coordinate and lead Computer System Validation (CSV) activities to ensure VWR computerized and automation systems are in full compliance with regulatory requirements, company policies, and procedures. Serve as the subject matter expert to provide compliance leadership and oversight to cross-functional team s Computer System Validation (CSV) projects. Collaborate with business partners to maintain and improve CSV processes to ensure robust, efficient, and compliant processes. Serve as the Systems CSV contact to management and business partners involved in CSV projects. Job Responsibilities: * Responsible for developing the CSV roadmap and further policy for present and future VWR IT Infrastructures. * Interface effectively with management personnel in IT, Engineering, Quality, R&D, and other technical disciplines. * Serves as the lead SME for CSV projects; including inquiries pertaining to the interpretation of FDA, EU, and other regulatory requirements for computer system validation. * Provides management with updates on projects, the health of the CSV process, and when necessary, communicates risk-based issue escalations. * Provide technical decision making regarding validation strategies and requirements for projects. * Strong understanding of IT network infrastructure and required qualification activities. * Expected to stay current with US and international regulations, industry standards, and emerging topics (e.g., cybersecurity) pertaining to computer software validation. * Provides compliant and pragmatic leadership to software validation projects throughout the computer system s software development lifecycle including system retirement. * Provides value-added guidance during the design, deployment, maintenance, and retirement of IT computer system. This guidance applies to all systems developed in house, developed by contractors, and off the shelf (OTS) software. May perform supplemental research to provide options for compliant solutions to barriers encountered during validation activities. * Reviews and approves software validation documentation to ensure documentation is compliant with IT procedures and all applicable quality system regulations or standards. * Organizes or conducts training on software validation principles and Part 11 requirements. * Exercises judgment in selecting methods and language to provide compliant solutions to address and document issues, which may arise during validation activities. Experience & Skills: * Prepare, review, and approve various computer validation documents for CSV projects including the following: * Regulatory Assessment for determination of GxP and Part 11 relevance * Validation Plan * Technical Documentation (e.g., User Requirement, Functional Requirements, Design Specifications) * Requirements of Trace Matrix * Risk Assessment * IQ/OQ/PQ Protocols and Reports * Validation Summary Report * Recommends and/or drives continuous improvement activities to streamline validation processes. Leads or supports CSV remediation activities. * Serves as the CSV SME for internal and external audits. * Ensures that the system s validation s