We are seeking a highly experienced and detail-oriented FDA Computer System Validation (CSV) Lead to ensure compliance with FDA and other authorized body (TUV, BSI, etc.) regulations and guidelines for computer systems within our organization. As the CSV Lead, you will be responsible for overseeing the validation of computer systems used in the development, manufacturing, and distribution of FDA-regulated products. You will collaborate with cross-functional teams to develop and execute validation strategies, ensure documentation and testing protocols meet regulatory requirements, and drive the successful implementation of validated systems.
What you will do:
Execute hands-on authoring, review and approval of computer system validation deliverables.
Continuously improve the Stryker comprehensive CSV strategy in alignment with FDA regulations and guidelines for computer systems used in regulated processes.
Provide guidance and expertise on CSV best practices, industry standards, and regulatory expectations to ensure compliance.
Collaborate with Quality Assurance and Compliance teams to ensure alignment between CSV activities and quality management systems (QMS) and standard operating procedures (SOPs).
Provide oversight and guidance on the validation activities performed by validation engineers and ensure adherence to established procedures and timelines.
Develop and deliver CSV training programs to stakeholders involved in system validation
Participate in FDA inspections and audits related to CSV activities, providing documentation and supporting evidence as required.
Collaborate with cross-functional teams to address and resolve CSV-related issues, deviations, and non-conformances.
What you need:
Bachelor's degree in Computer Science, Engineering, or a related field. Advanced degree is a plus.
Minimum of 3 year’s experience in FDA-regulated industries, with a strong focus on computer system validation.
Thorough understanding of FDA regulations and guidelines related to CSV, including 21 CFR Part 11, 21 CFR Part 820, and GAMP (Good Automated Manufacturing Practice) standards.
Proven experience leading and managing CSV activities for complex computer systems in a regulated environment.
Excellent knowledge of CSV methodologies, validation protocols, risk management, and change control processes.
Strong understanding of software development life cycle (SDLC) methodologies, including agile and waterfall approaches.
Familiarity with various types of computer systems used in FDA-regulated processes, such as laboratory information management systems (LIMS), electronic data capture (EDC) systems, and manufacturing execution systems (MES).
Strong project management skills with the ability to effectively plan, prioritize, and execute multiple validation projects concurrently.
Excellent written and verbal communication skills, including the ability to communicate complex concepts and requirements to both technical and non-technical stakeholders.
Strong analytical and problem-solving abilities, with a keen attention to detail.
Knowledge of validation tools, testing methodologies, and automated validation solutions is a plus.
Experience with electronic document management systems (EDMS) and validation software is preferred.
Travel Percentage: 20%