This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Computer Systems Validation Analyst II based in the United States. Join a mission-driven biotechnology environment dedicated to advancing innovative treatments and improving outcomes for patients with serious diseases. As a Computer Systems Validation Analyst II, you will play a key role in ensuring that computerized systems used across laboratory, manufacturing, and enterprise operations meet stringent quality and regulatory standards. You will manage validation activities throughout the system lifecycle, from requirements documentation and risk assessments to testing, qualification, and compliance reviews. Working closely with technical teams, business stakeholders, and end users, you will help deliver reliable, compliant, and well-documented systems. This role offers the opportunity to apply your expertise in regulated environments while supporting data integrity and operational excellence. If you are detail-oriented, proactive, and comfortable managing multiple projects in a fast-paced setting, this is an opportunity to make a meaningful impact. Accountabilities - Manage the computer systems validation lifecycle: Execute and document validation activities from planning and requirements definition through testing, qualification, implementation, and final compliance review. - Ensure regulatory compliance: Apply relevant regulatory standards, including 21 CFR Part 11, EU Annex 11, GAMP 5, and ALCOA+ data integrity principles, to maintain compliant computerized systems. - Develop validation documentation: Prepare and maintain validation plans, risk assessments, user and functional requirements, specifications, data integrity assessments, test scripts, qualification protocols, traceability matrices, change controls, and validation reports.
- Support cross-functional system implementation: Collaborate with laboratory, manufacturing, information technology, and enterprise teams to ensure computerized systems are validated and delivered on time and within budget. - Coordinate project execution: Prioritize validation activities, track milestones, manage dependencies, resolve issues, and provide regular progress updates to management, clients, and end users. - Manage change controls and periodic reviews: Complete assigned change-control actions and coordinate periodic reviews of computerized systems to maintain ongoing compliance, data quality, and data integrity. - Apply software development lifecycle methodologies: Adapt validation activities to Agile, Waterfall, and hybrid software development lifecycle (SDLC) approaches, ensuring appropriate documentation and controls. - Resolve technical and compliance issues: Investigate validation challenges, coordinate with internal and external stakeholders, and support timely escalation and resolution of complex issues. - Maintain quality and professional standards: Follow established policies, procedures, business ethics, and quality requirements while identifying opportunities to improve validation processes and documentation practices. Requirements - Education: Bachelor's degree in Information Technology, Life Sciences, Engineering, or another relevant technical discipline, or equivalent practical qualifications. - Professional experience: At least five years of relevant industry experience in computer systems validation, quality assurance, information technology, or a related function within a regulated environment. - Regulatory knowledge: Strong understanding of computer systems validation requirements, including 21 CFR Part 11, EU Annex 11, GAMP 5, and ALCOA+ data integrity principles. - Validation lifecycle expertise: Demonstrated experience preparing and executing validation documentation, risk assessments, requirements specifications, testing, qualification protocols, traceability matrices, change controls, and compliance reviews.
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