Computer System Validation Engineer (I, II, III)

Responsibilities

• Work closely with the Engineering teams, providing quality direction and guidance to the development and the design control processes, defining the quality assurance expectations for design planning strategies and ensuring that each stage of the design and development is adequately documented, recorded and maintained
• Create quality documentation, protocols, reports, specifications, templates and developing of procedures to ensure a systemic process for design and development, ensuring compliance with regulatory requirements throughout the development and the product life cycle
• Perform independent reviews of the Computer System Validation (CSV) deliverables, from the requirements gathering phase to the retirement phase
• Work collaboratively with cross functional teams to define a process and a set of documentation to support and verify the progress of the design and development activities and for managing and controlling the design and development and transferring it to manufacturing
• Review documentation associated with planning, intended use, user requirements, hazard analysis, risk assessments, functional and design specifications, design reviews, test protocols, 21 CFR Part 11 compliance assessments, requirements trace matrix, Master Validation Plan, V&V packages along with support documentation for equipment and systems
• Collaborate with cross functional teams, including external parties to establish verification and validation plans for test methods, equipment, processes and products using appropriate techniques and identification of risks through execution of FMEA and Risk Analysis
• Review and approve changes to existing systems from a Software Quality perspective ensuring changes are implemented in compliance with internal procedures and external standards
• Perform periodic reviews for validated systems and defending the practice and outcomes of software validation
• Drive root cause analysis investigations and CAPAs and actively participate in continuous improvement activities with cross-functional teams
• Conduct quality audits
• Establish and promote an environment that supports the Quality Policy, Data Integrity and Quality System
• Deep understanding of ALCOA, GAMP 5,  ISO 13485, ISO 14971, ICH Q9 , 21CFR820, 21 CFR Parts 210,211and part 11 requirements for Computerized Systems including, but not limited to, manufacturing equipment, laboratory equipment, and enterprise software systems

Requirements

• Bachelor's level degree or higher in Science, Engineering, or Software discipline
• 3+ years of related work experience in Software Quality Engineering and Computer System Validation (CSV)
• Experience working in an FDA-regulated industry
• Knowledge of Software development life cycles (SDLC) preferably with automated manufacturing and computerized lab systems
• Understanding of data integrity requirements and how to perform assessments
• Practical knowledge of 21 CFR Part 11 (electron records/electronic signature), 21 CFR Parts 210,211, GAMP 5, 21 CFR Part 820, ISO 13485, and ISO 14971 
• Experience in supporting automated manufacturing equipment desired
• Must possess excellent organizational, clear verbal, and written communication skills
• High level of attention to detail and compliance and ability to effectively support multiple high priority deliverables at once
• Hands on approach, self-motivated with a passion for solving problems
• Self-awareness, integrity, authenticity, and a growth/entrepreneurial mindset