Software Validation Engineer / CSV - IT

Reporting to the Manager andtherole involves

What a typical day looks like:

• Good Experience in executing Medical industries software validations, having led and managed projects.
• Strong working knowledge of applied statistics, quality systems, and regulatory requirements across multiple health authorities including 21 CFR 820, 21 CFR Part 11, ISO 14971, ISO 13485, FDA, EU Medical Device Regulation, GAMP, GPSV, and CSV/CSA
• High-level strategic problem-solving and reasoning skills. Analyzes evaluates and presents information concerning findings, trends with IT in business, and development.
• Ensure adherence to software validation processes and perform review & approval for all the software validation activities.
• Suggests and debates to implement the right SDLC, software validation methods, and procedures with Flex.
• Train and coach project team members on achieving quality in project deliverables (e.g. GDP, V&V Process, CSV, project-related risks management, resolving the issues by following the right process, and SOP requirements).
• Conducts meetings (technical & management) to review investigation findings related to IT systems.
• Cooperates with other department personnel and peers in understanding needs and identifying opportunities for improvements.
• Serve as the SME for CSV, maintaining the knowledge and information in the CSV area of expertise.
• Perform software validation activities
• Liaise between IT, Quality, Project Team, Corporate Quality team, and various regulatory bodies.
• Keep abreast of regulatory developments within or outside of the company as well as evolving best practices in compliance control.
• Prepare reports for senior management and external regulatory bodies as appropriate.
• Escalate non-compliance with a resolution for the fundamental CSV compliance issues.
• Support the project team to perform audit readiness and project audits.
• Expected to travel (domestic/internationally) when needed to meet with Flex facility project Teams.
• Work collaboratively with different departments located in a different geography.

The experience were looking to add to our team:

• 5 - 10 years of experience in Medical/Life Sciences industries software validation and compliance reviews.
• Strong working knowledge of applied statistics, quality systems, and regulatory requirements across multiple health authorities including 21 CFR 820, 21 CFR Part 11, ISO 14971, ISO 13485, FDA, EU Medical Device Regulation, GAMP, GPSV, and CSV/CSA
• High-level strategic problem-solving and reasoning skills. Analyzes evaluates and presents information concerning findings, trends with IT in business, and development.
• Ensure adherence to software validation processes and perform review & approval for all the software validation activities.
• Suggests and debates to implement the right SDLC, software validation methods, and procedures with the Flex.