System Validation Engineer

Computer Systems Validation (CSV) Engineer The CSV Engineer will be a key member of the Computer Systems Validation (CSV) team, providing support for computer system validation across ITJ's 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. Essential Duties Include, but are not limited to, the following: 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. Advanced Duties Include, but are not limited to, the following: 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. Minimum Qualifications 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 4 years of relevant experience as outlined in the essential duties instead of a bachelor’s degree. 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. Preferred Qualifications 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. Apply now!

Location: México, MX

Posted Date: 6/16/2025