The CSV Engineer will be a key member of the Computer Systems Validation (CSV) team, providing support for computer system validation across the IT Systems. This role will assist in validation and qualification activities using a risk-based approach, including developing and executing Software Development Life Cycle (SDLC) documents such as business/functional requirements, risk assessments, and validation plans.

• Support activities related to validation, including periodic reviews, system risk assessments, and associated tasks in the service management software.
• Maintain meeting minutes, organize tasks, and identify and communicate potential areas for process improvements.
• Assist in drafting Computer System Assurance (CSA) documents (e.g. test plans based on risk level analysis and/or CSV test protocols (e.g. IQ/OQ/PQ).
• Work closely with cross-functional teams (Quality, IT, Engineering, Manufacturing) to ensure systems are validated and compliant.
• Support and comply with the company’s Quality Management System (QMS) policies and procedures. 
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork. 
• Maintain regular and reliable attendance. 
• Ability to act with a quality mindset and model these behaviors for the organization. 
• Independently carry out assigned CSV deliverables within the given constraints of scope, time, and schedule. 
• Communicate validation status, issues, and risks to stakeholders.
• Assist and monitor investigations and preventive/corrective actions for validation activities, including authoring and/or reviewing RCIA, CAPAs, SDLC documents, and deviations.
• Participate in audits and continuous improvement efforts related to the CSV program.
• Work with Senior CSV Engineers to prioritize initiatives to align with strategic goals.
• Provide regular, accurate, and timely reporting of CSV projects to compliance leaders and stakeholders.

• Bachelor’s degree in health-related Sciences, Engineering, Computer Science, Information Technology, or field as outlined in the essential duties; or High School Diploma or General Education Degree (GED) and 3 years of relevant experience as outlined in the essential duties instead of a bachelor’s degree.
• 3 - 5 years of experience
• Experience working with regulatory frameworks such as ISO 13485, FDA (21 CFR part 11, 21 CFR part 820), and GAMP5.
• 3+ years of experience in the medical device, biological, pharmaceutical, or other FDA or GxP-regulated industry.
• Previous experience and knowledge of CSV methodologies and/or SDLC.
• Proven ability to work within a fast-paced, cross-functional team environment.
• Demonstrated ability to perform the essential duties of the position with minimal assistance. 
• Experience in developing, reviewing, and executing validation and change control documents within a QMS.
• Customer-focused; action-oriented; building team spirit; self-development; creativity & innovation; problem-solving; ethics & values.
• Experience working with SAP, Jira, and/or ServiceNow.