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.
- 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.
- Regulated systems experience: Familiarity with computerized system lifecycle activities and IT controls, ideally supporting laboratory, manufacturing, or enterprise applications across multiple sites.
- Project management skills: Ability to coordinate complex validation activities, manage competing priorities, meet deadlines, and deliver projects within defined timelines and quality expectations.
- Methodology knowledge: Experience working with Agile, Waterfall, and hybrid SDLC models in regulated systems environments.
- Communication and collaboration: Strong written and verbal communication skills, with the ability to explain technical and compliance matters clearly and work effectively with internal teams, external partners, management, and end users.
- Attention to detail: A highly organized and methodical approach to documentation, with a strong commitment to accuracy, traceability, and regulatory compliance.
- Problem-solving abilities: Sound judgment, analytical thinking, troubleshooting skills, and the ability to navigate complex issues while maintaining quality standards.
- Autonomy and initiative: A proactive, self-motivated mindset, with the ability to work independently, anticipate validation needs, and drive assignments to completion with minimal supervision.
- Adaptability: Comfort working in a fast-paced environment, handling multiple priorities, responding to changing requirements, and maintaining performance under pressure.
- Remote work readiness: Ability to work effectively in a professional remote or office environment, communicate with stakeholders, and maintain a safe, productive workspace.
Benefits
- Competitive salary: Annual base salary ranging from $120,000 to $135,000 USD, depending on work location, relevant experience, qualifications, skills, and the responsibilities of the role.
- Remote work flexibility: Opportunity to work remotely in the United States, with a professional and well-equipped home office environment.
- Meaningful impact: Contribute to the quality, compliance, and reliability of systems supporting advanced biotechnology and patient-focused therapeutic development.
- Professional development: Opportunities to strengthen expertise in computer systems validation, regulated technologies, data integrity, and quality systems.
- Collaborative environment: Work with cross-functional teams across technical, laboratory, manufacturing, and enterprise operations.
- Inclusive workplace: Join an organization committed to equal employment opportunities, diversity, and an inclusive working environment.
- Workplace accommodations: Reasonable accommodations are available to qualified individuals throughout the application process and for the performance of essential job functions.
