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Computer System Validation Csv Remote Jobs in California

Tempus

Senior Quality Engineer

Redwood City, CA · On-site +1

Lead computer system validation (CSV) activities of Tempus AI applications, software tools, and ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...

Vaxcyte

Manager, IT Quality & Compliance

San Carlos, CA · On-site +1

IT Validation & CSV/CSA Execution * Execute Computer Software Assurance (CSA) and Computer System ... Open to Remote; San Carlos, CA Compensation: The compensation package will be competitive and ...

General Motors

Senior ML Validation Engineer

Sunnyvale, CA · On-site +1

$144K - $261K/yr

Collaborate with Simulation, Safety, Systems Engineering, and cross-functional partners. * Author ... MS + 5 years, or PhD + 3 years in ML, Robotics, Computer Science, or work related experience

Ankura

Model Validation Director

San Francisco, CA · On-site +1

Ideally this role will be hybrid based out of one of our locations; however, remote locations will ... Computer Science, Management Information Systems, or Statistics/Mathematics. * Experience with data ...

Ankura

Model Validation Director

Los Angeles, CA · On-site +1

Ideally this role will be hybrid based out of one of our locations; however, remote locations will ... Computer Science, Management Information Systems, or Statistics/Mathematics. * Experience with data ...

Bluelight Consulting

$134K - $161K/yr

Implement data quality checks and validation processes to maintain data accuracy and consistency ... Bachelor's degree in Computer Science, Information Technology, or a related field; or equivalent ...

Bluelight Consulting

$134K - $161K/yr

Implement data quality checks and validation processes to maintain data accuracy and consistency ... Bachelor's degree in Computer Science, Information Technology, or a related field; or equivalent ...

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All JobsComputer System Validation Csv Remote JobsComputer System Validation Csv Remote Jobs in California

Computer System Validation Csv Remote information

What is a Computer System Validation (CSV) specialist and what do they do remotely?

A Computer System Validation (CSV) specialist is responsible for ensuring that computer systems used in regulated industries, such as pharmaceuticals or biotechnology, meet all required compliance standards and function as intended. When working remotely, CSV specialists perform tasks like developing validation protocols, reviewing documentation, executing test scripts, and liaising with teams via digital tools to ensure systems adhere to regulatory guidelines. Their work helps guarantee data integrity, product quality, and regulatory compliance in industries where strict standards are critical.

What is the difference between Computer System Validation Csv Remote vs Computer Validation Specialist?

AspectComputer System Validation Csv RemoteComputer Validation Specialist
CertificationsGxP, 21 CFR Part 11, CSV certificationsGxP, 21 CFR Part 11, CSV certifications
Work EnvironmentRemote, regulated industries like pharma and biotechOn-site or hybrid in regulated industries
Industry UsagePharmaceutical, biotech, medical devicesPharmaceutical, biotech, medical devices
Job FocusValidating computer systems and software complianceValidating computer systems and software compliance

Both roles require similar certifications and work in regulated industries like pharma and biotech. The main difference is that Computer System Validation Csv Remote typically involves remote work, focusing on validating computer systems remotely, while Computer Validation Specialist may work on-site or in hybrid settings. Both roles aim to ensure compliance with industry standards and regulations.

What are some common challenges faced by Computer System Validation (CSV) professionals working remotely, and how can they be addressed?

Remote CSV professionals often encounter challenges such as coordinating validation activities across different teams, ensuring secure access to validation environments, and maintaining clear documentation. Effective communication is key—using project management tools and regular virtual meetings helps keep everyone aligned. It's also important to implement robust cybersecurity measures and standardized documentation practices to ensure compliance. Proactively addressing these challenges fosters a smooth validation process and supports regulatory requirements.

What are the key skills and qualifications needed to thrive as a Computer System Validation (CSV) specialist in a remote role, and why are they important?

To excel as a Computer System Validation (CSV) specialist, you need a solid background in computer science or life sciences, experience with GxP regulations, and knowledge of validation documentation standards. Familiarity with validation management tools, electronic quality management systems (eQMS), and understanding regulatory frameworks like FDA 21 CFR Part 11 or EU Annex 11 is crucial. Strong attention to detail, problem-solving skills, and effective remote communication set top performers apart. These competencies ensure validated systems meet compliance requirements, maintain data integrity, and support regulatory audits in remote environments.
What are the most commonly searched types of Computer System Validation Csv jobs in California? The most popular types of Computer System Validation Csv jobs in California are:
What are popular job titles related to Computer System Validation Csv Remote jobs in California? For Computer System Validation Csv Remote jobs in California, the most frequently searched job titles are:
What job categories do people searching Computer System Validation Csv Remote jobs in California look for? The top searched job categories for Computer System Validation Csv Remote jobs in California are:
What cities in California are hiring for Computer System Validation Csv Remote jobs? Cities in California with the most Computer System Validation Csv Remote job openings:
Computer System Validation Csv Remote jobs near you
Infographic showing various Computer System Validation Csv Remote job openings in California as of June 2026, with employment types broken down into 3% Internship, 81% Full Time, 5% Part Time, 3% Temporary, and 8% Contract. Highlights an 100% Remote job distribution.
Senior Quality Engineer

Senior Quality Engineer

Tempus

Redwood City, CA • On-site, Remote

Full-time

Posted 11 days ago

Job description

Passionate about precision medicine and advancing the healthcare industry?

Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.

PLEASE NOTE: This is a hybrid role requiring three days a week in the office. Candidates can be based out of our Chicago (Headquarters), New York, or Redwood City locations.

As a Senior Quality Engineer, you will:

  • Lead verification, validation and maintenance of host systems supporting Tempus Medical Device(s).

  • Lead risk assessments to determine testing strategies.

  • Be involved in the medical device software design controls activities, in accordance with the FDA Quality System Regulation, ISO 13485, GAMP5, Computer System Validation (CSV) standards and FDA guidance, other applicable regulatory requirements, as well as best practices in the software industry.

  • Lead computer system validation (CSV) activities of Tempus AI applications, software tools, and computer systems against user, functional and regulatory requirements.

Responsibilities:

  • Support regulatory compliance of the host system operating with Tempus Medical Device(s).

  • Develop and maintain CSV policies, procedures, templates and work instructions.

  • Lead risk-based approach to host / computer system validation (HSV/CSV), SDLC and design controls activities.

  • Perform validation, re-validation and change controls of various AI, SaaS, and Tempus in-house developed software.

  • Author and review software validation deliverables, including Risk Assessments, Validation Plans, Requirements (URS), Validation Protocols (IQ, OQ, PQ), UAT (User Acceptance Test), and Validation Reports.

  • Collaborate with cross-functional teams in developing test-driven system/functional requirements, defining testing strategies and participating in test execution.

  • Support Change Management and Major Incidents (MI) processes, ensuring organizational compliance and continuous improvement.

  • Provide support to Quality and IT organizations in maintaining compliance to various policies, procedures and activities, including support during internal/external inspections and regulatory and customer audits.

  • Provide CSV guidance, coaching, mentorship, and training to test engineers within the team.

Qualifications

  • BA/B.S. or higher preferred in Computer Science, Software Engineering, Informatics, Biomedical, or relevant engineering disciplines.

  • 5+ years experience in FDA regulated domain (e.g. medical device, pharma, biotech)

  • 3+ years experience in Computer System Validation (CSV).

  • Experience with industry standards and best practices for Medical device software and CSV such as Design Controls, GAMP 5, FDA 21 CFR Part 11, FDA (QSR) FDA 21 CFR 820.30, Medical device software (QMS) ISO 13485:2016, FDA 21 CFR 820, and Software life cycle processes (IEC 62304:2006).

  • Knowledge of quality system principles, practices, and standards for the life science industry.

  • Ability to deliver quality outputs without directions or under minimal supervision.

Chicago Pay Range: $90,000-$130,00

NYC/SF Pay Range: $100,000-$150,000

The expected salary range above is applicable if the role is performed from California and may vary for other locations (Colorado, Illinois, New York). Actual salary may vary based on qualifications and experience. Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position.

Additionally,for remote roles open to individuals in unincorporated Los Angeles - including remote roles-Tempus reasonably believes that criminal history may have a direct, adverse and negative relationship on the following job duties, potentially resulting in the withdrawal of the conditional offer of employment: engaging positively with customers and other employees; accessing confidential information, including intellectual property, trade secrets, and protected health information; and appropriately handling such information in accordance with legal and ethical standards. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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