Validation Lead (CSV/CSA) (Contractor)

The Impact You’ll Make

As a Validation Lead/Validation Engineer at Recursion, you will be at the forefront of ensuring the overall quality performance and compliance throughout the organization by defining, implementing, and maintaining a risk-based computer system validation and assurance program (CSV/CSA). Your role will directly support Recursion's mission to decode biology by enabling cutting-edge research and innovation through reliable IT services. From ensuring operational excellence in systems performance to driving proactive solutions for security and compliance, you’ll play a key role in empowering teams across the company to achieve their goals.

Please note: This is a 6-month contract role. 

In this role, you will:

Validation Strategy and Execution:

• Spearhead the development and execution of comprehensive, risk-based validation strategies, protocols, and activities for both on-premise and cloud-based computerized systems within a clinical stage environment.
• Ensure full adherence to GxP and FDA regulations, as well as other relevant industry standards and best practices, such as 21 CFR Part 11.
• Orchestrate and oversee a spectrum of validation activities, including but not limited to:
1. Requirements gathering and documentation
2. Risk assessments and mitigation strategies
3. Test plan development and execution
4. Traceability matrix establishment and maintenance
5. Deviation and incident management
6. Change control oversight
7. Validation report generation and approval

Qualification & Validation Documentation:

• Take ownership of the creation, review, and approval of essential validation documentation, including Standard Operating Procedures (SOPs), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Validation Master Plans (VMPs), User Requirements Specifications (URS), and other related documents.
• Guarantee strict compliance with GAMP guidelines and other applicable quality standards.

Risk & Compliance Assessment:

• Proactively conduct thorough risk assessments, impact analyses, and validation gap analyses to identify and mitigate potential compliance risks.
• Maintain a constant state of regulatory compliance and readiness for audits and inspections.

Manage CSV/A Activities:

• Collaborate closely with external vendors and Managed Service Providers (MSPs) to ensure seamless execution of Computer System Validation and Assurance (CSV/CSA) activities, including testing and documentation, in accordance with established procedures and protocols.

Regulatory & Audit Support:

• Play a key role in preparing for and supporting regulatory audits, inspections, and other compliance activities.
• Serve as a subject matter expert and liaison with regulatory agencies.

Deviation & CAPA Management:

• Lead investigations into deviations and non-conformances, perform root cause analysis, and implement effective Corrective and Preventive Actions (CAPAs) to prevent recurrence.

IT Systems & Service Management:

• Provide support for critical IT systems and infrastructure.
• Utilize ServiceNow and/or a Quality Management System (QMS) for efficient tracking, documentation, and management of validation activities and compliance tasks.
• Ensure that IT systems and services remain compliant with relevant regulations and standards.

Cross-Functional Collaboration:

• Foster strong collaborative relationships with key stakeholders across IT, Quality Assurance (QA), Engineering, and Clinical Development teams to ensure effective and efficient validation execution.
• Facilitate clear communication and alignment of business goals across departments.
• Mentor and provide training for internal resources on GxP and 21 CFR Part 11 validation activities.

Continuous Improvement & Technical Support:

• Proactively identify opportunities for process optimization, scalability, and improvement within the validation framework.
• Leverage technical expertise and industry knowledge to enhance validation operations and support overall business objectives.
• Stay abreast of emerging trends and technologies in the field of computer system validation.
• Stay updated on evolving regulatory trends and industry best practices.

The Team You’ll Join

The IT team at Recursion is a dynamic group of specialists, engineers, and administrators dedicated to securely enabling Recursion to move fast and innovate. Collaborating across departments, the team focuses on maintaining cutting-edge systems and infrastructure while driving forward strategic projects. From managing complex cloud platforms to delivering resilient on-premises solutions, the IT team thrives on solving challenges and fostering a supportive, inclusive culture.

The Experience You’ll Need:

• 7+ years of experience in computer system validation/assurance within a GxP-regulated industry (pharmaceutical, biotech, medical devices).
• Strong understanding of FDA regulations, ICH guidelines, and industry best practices related to qualification and validation.
• Proven expertise in GxP, 21 CFR Part 11, CSV/A 
• Expertise in drafting and executing qualification protocols (IQ, OQ, PQ) and validation documentation (VMPs, URS, etc.).
• Strong experience with procedural development, risk assessments, impact assessments, and regulatory compliance audits.
• Strong analytical, organizational, and communication skills.
• Bachelor's degree in Engineering, Life Sciences, or a related field (Master’s preferred)
• Experience with ERP, MES, LIMS, EDMS, QMS

 

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