BioSpace
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Validation Lead (CSV/CSA) (Contractor)
role at
BioSpace .
Your work will change lives, including your own.
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 in other relevant industry standards and best practices, including 21 CFR Part 11.
Orchestrate and oversee a spectrum of validation activities, including but not limited to:
Requirements gathering and documentation
Risk assessments and mitigation strategies
Test plan development and execution
Traceability matrix establishment and maintenance
Deviation and incident management
Change control oversight
Validation report generation and approval
Qualification & Validation Documentation
Take ownership of the creation, review, and approval of essential validation documentation, including SOPs, IQ, OQ, PQ, VMPs, 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 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, Engineering, and Clinical Development teams.
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.
The Values We Hope You Share
We act boldly with integrity. We are unconstrained in our thinking, take calculated risks, and push boundaries, but never at the expense of ethics, science, or trust.
We care deeply and engage directly. Caring means holding a deep sense of responsibility and respect - showing up, speaking honestly, and taking action.
We learn actively and adapt rapidly. Progress comes from doing. We experiment, test, and refine, embracing iteration over perfection.
We move with urgency because patients are waiting. Speed isn’t about rushing but about moving the needle every day.
We take ownership and accountability. Through ownership and accountability, we enable trust and autonomy—leaders take accountability for decisive action, and teams own outcomes together.
We are One Recursion. True cross-functional collaboration is about trust, clarity, humility, and impact. Through sharing, we can be greater than the sum of our individual capabilities.
More About Recursion Recursion (NASDAQ: RXRX) is a clinical-stage TechBio company leading the space by decoding biology to radically improve lives. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously generate one of the world’s largest proprietary biological and chemical datasets. Recursion leverages sophisticated machine-learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale — up to millions of wet lab experiments weekly — and massive computational scale — owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology and chemistry to advance the future of medicine.
Recursion is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. Recursion also has offices in Toronto, Montréal, New York, London, Oxford area, and the San Francisco Bay area. Learn more at www.Recursion.com, or connect on X (formerly Twitter) and LinkedIn.
Equal Opportunity Employer Recursion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, local, or provincial human rights legislation.
Accommodations Accommodations are available on request for candidates taking part in all aspects of the selection process.
Recruitment & Staffing Agencies Recursion Pharmaceuticals and its affiliate companies do not accept resumes from any source other than candidates. The submission of resumes by recruitment or staffing agencies to Recursion or its employees is strictly prohibited unless contacted directly by Recursion’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Recursion, and Recursion will not owe any referral or other fees. Our team will communicate directly with candidates who are not represented by an agent or intermediary unless otherwise agreed to prior to interviewing for the job.
Seniority Level Mid‑Senior level
Employment Type Contract
Job Function Other
Industries Internet News
#J-18808-Ljbffr
Validation Lead (CSV/CSA) (Contractor)
role at
BioSpace .
Your work will change lives, including your own.
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 in other relevant industry standards and best practices, including 21 CFR Part 11.
Orchestrate and oversee a spectrum of validation activities, including but not limited to:
Requirements gathering and documentation
Risk assessments and mitigation strategies
Test plan development and execution
Traceability matrix establishment and maintenance
Deviation and incident management
Change control oversight
Validation report generation and approval
Qualification & Validation Documentation
Take ownership of the creation, review, and approval of essential validation documentation, including SOPs, IQ, OQ, PQ, VMPs, 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 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, Engineering, and Clinical Development teams.
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.
The Values We Hope You Share
We act boldly with integrity. We are unconstrained in our thinking, take calculated risks, and push boundaries, but never at the expense of ethics, science, or trust.
We care deeply and engage directly. Caring means holding a deep sense of responsibility and respect - showing up, speaking honestly, and taking action.
We learn actively and adapt rapidly. Progress comes from doing. We experiment, test, and refine, embracing iteration over perfection.
We move with urgency because patients are waiting. Speed isn’t about rushing but about moving the needle every day.
We take ownership and accountability. Through ownership and accountability, we enable trust and autonomy—leaders take accountability for decisive action, and teams own outcomes together.
We are One Recursion. True cross-functional collaboration is about trust, clarity, humility, and impact. Through sharing, we can be greater than the sum of our individual capabilities.
More About Recursion Recursion (NASDAQ: RXRX) is a clinical-stage TechBio company leading the space by decoding biology to radically improve lives. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously generate one of the world’s largest proprietary biological and chemical datasets. Recursion leverages sophisticated machine-learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale — up to millions of wet lab experiments weekly — and massive computational scale — owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology and chemistry to advance the future of medicine.
Recursion is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. Recursion also has offices in Toronto, Montréal, New York, London, Oxford area, and the San Francisco Bay area. Learn more at www.Recursion.com, or connect on X (formerly Twitter) and LinkedIn.
Equal Opportunity Employer Recursion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, local, or provincial human rights legislation.
Accommodations Accommodations are available on request for candidates taking part in all aspects of the selection process.
Recruitment & Staffing Agencies Recursion Pharmaceuticals and its affiliate companies do not accept resumes from any source other than candidates. The submission of resumes by recruitment or staffing agencies to Recursion or its employees is strictly prohibited unless contacted directly by Recursion’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Recursion, and Recursion will not owe any referral or other fees. Our team will communicate directly with candidates who are not represented by an agent or intermediary unless otherwise agreed to prior to interviewing for the job.
Seniority Level Mid‑Senior level
Employment Type Contract
Job Function Other
Industries Internet News
#J-18808-Ljbffr