Validation Lead

Summary

Join Recursion as a Validation Lead/Validation Engineer and play a pivotal role in ensuring the quality, performance, and compliance of computer systems. This 6-month contract position involves developing and executing risk-based validation strategies, adhering to GxP and FDA regulations, and managing validation documentation. You will collaborate with various teams, conduct risk assessments, and support regulatory audits. The ideal candidate possesses extensive experience in computer system validation within a GxP-regulated industry and a strong understanding of relevant regulations and guidelines. This role offers the opportunity to contribute to cutting-edge research and innovation within a dynamic and supportive team environment.

Requirements

• 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
• Experience with ERP, MES, LIMS, EDMS, QMS

Responsibilities

• 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: Requirements gathering and documentation
• Orchestrate and oversee a spectrum of validation activities, including but not limited to: Risk assessments and mitigation strategies
• Orchestrate and oversee a spectrum of validation activities, including but not limited to: Test plan development and execution
• Orchestrate and oversee a spectrum of validation activities, including but not limited to: Traceability matrix establishment and maintenance
• Orchestrate and oversee a spectrum of validation activities, including but not limited to: Deviation and incident management
• Orchestrate and oversee a spectrum of validation activities, including but not limited to: Change control oversight
• Orchestrate and oversee a spectrum of validation activities, including but not limited to: Validation report generation and approval
• 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
• 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
• 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
• 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
• Lead investigations into deviations and non-conformances, perform root cause analysis, and implement effective Corrective and Preventive Actions (CAPAs) to prevent recurrence
• 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
• 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
• 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

Preferred Qualifications

Master’s degree