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Senior Computer System Validation Csv Jobs in California

Nanda Technologies

CSV Engineer

Costa Mesa, CA · On-site

$55 - $60/hr

CSV Engineer Costa Mesa, CA or Seattle, WA(On-site) Visa: USC, GC & H4 EAD Key Responsibilities ... Computer system validation methodologies * Familiarity with risk-based validation execution ...

Cerus

IT Portfolio & Project Manager

Concord, CA · Hybrid

$108K - $127K/yr

Computer System Validation (CSV) and Regulatory Compliance * Coordinate and support Computer System Validation (CSV) activities, including validation planning, execution, and documentation, in ...

PSC Biotech

SAP CSV Lead

San Francisco, CA · Remote

$40 - $53/hr

Your Role We are seeking an experienced SAP CSV Lead to provide strategic leadership and oversight for Computer System Validation (CSV) and Computer Software Assurance (CSA) activities supporting SAP ...

The Remas Company, LLC

Project Manager

La Verne, CA · On-site

This position is also responsible for monitoring Computer System validation (CSV) as well as compliance with GxP regulations and 21 CFR Part 11. * Leads the effort to manage, and/or maintains ...

Cerus

IT Portfolio & Project Manager

Concord, CA · On-site

$108K - $127K/yr

Computer System Validation (CSV) and Regulatory Compliance * Coordinate and support Computer System Validation (CSV) activities, including validation planning, execution, and documentation, in ...

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Senior Computer System Validation Csv information

What is a senior computer system validation (CSV) specialist?

A Senior Computer System Validation (CSV) specialist is an experienced professional responsible for ensuring that computer systems used in regulated industries—such as pharmaceuticals, biotechnology, or medical devices—meet compliance standards. This involves planning, executing, and documenting validation activities to demonstrate that systems consistently perform according to predefined specifications and regulatory requirements. Senior CSV specialists often lead validation projects, manage teams, and interact with regulatory auditors, making sure that systems are reliable, secure, and compliant with guidelines like FDA 21 CFR Part 11 and GxP. Their expertise helps organizations avoid compliance issues, data integrity problems, and costly system failures.

What are the key skills and qualifications needed to thrive as a senior computer system validation (CSV) professional?

To excel as a Senior Computer System Validation (CSV) professional, you need deep knowledge of regulatory compliance (such as FDA 21 CFR Part 11), validation lifecycle methodologies, and a background in computer science, engineering, or life sciences. Familiarity with validation management tools, risk assessment software, and quality management systems (QMS) is typically required, along with certifications like GAMP or Six Sigma being highly valued. Outstanding analytical skills, attention to detail, and strong communication abilities set high performers apart in this role. These competencies ensure validated systems meet regulatory requirements, maintain data integrity, and support quality operations in regulated industries.

What are some common challenges senior computer system validation (CSV) professionals face when working on large-scale projects?

Senior CSV professionals often encounter challenges such as coordinating validation activities across multiple departments, managing evolving regulatory requirements, and ensuring thorough documentation throughout the project lifecycle. They also need to balance project timelines with the need for comprehensive testing and risk assessments. Effective communication and collaboration with IT, QA, and business stakeholders are essential to address issues proactively and ensure compliance in complex, regulated environments.

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

AspectSenior Computer System Validation CsvComputer System Validation Specialist
CertificationsGxP, 21 CFR Part 11, CSV certificationsGxP, 21 CFR Part 11, CSV certifications
Work EnvironmentRegulated industries like pharma, biotech, medical devicesRegulated industries like pharma, biotech, medical devices
ResponsibilitiesLeading validation projects, ensuring compliance, mentoringExecuting validation activities, documentation, testing

While both roles require similar certifications and work in regulated environments, the Senior Computer System Validation Csv typically involves leading projects and overseeing compliance efforts, whereas the Computer System Validation Specialist focuses on executing validation tasks and documentation. The senior role often requires more experience and leadership responsibilities.

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 Senior Computer System Validation Csv jobs in California?

For Senior Computer System Validation Csv jobs in California, the most frequently searched job titles are:

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The top searched job categories for Senior Computer System Validation Csv jobs in California are:

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Cities in California with the most Senior Computer System Validation Csv job openings:

Senior Computer System Validation Csv jobs near you
Infographic showing various Senior Computer System Validation Csv job openings in California as of August 2026, with employment types broken down into 1% As Needed, 87% Full Time, 10% Part Time, and 2% Contract. Highlights an 91% Physical, 3% Hybrid, and 6% Remote job distribution.

Quality Assurance Manager- Hybrid

Sanguine Biosciences, Inc.

Los Angeles, CA • On-site

$110K - $115K/yr

Full-time

Re-posted 21 days ago

Job description

About Sanguine Biosciences, Inc.
Sanguine Biosciences is accelerating personalized medicine research by empowering patients with their healthcare data and making it as easy as possible for them to participate in the medical research process. We partner with patients and pharmaceutical companies to accelerate precision medicine R&D by securely and efficiently collecting and providing patient samples and relevant health data. We are helping thousands of researchers at 20 of the top 40 global pharmaceutical and biotechnology companies increase the speed and quality at which they are conducting their research. It is an exciting time; our biotech company is growing quickly and needs the best team members to join us.
About the Role:
The Quality Assurance Manager provides day-to-day leadership for key Quality Management System (QMS) processes and the Quality team, ensuring continued suitability, compliance, and scalability of the QMS as the business grows. This role is accountable for oversight and effectiveness of change control, Computer System Validation (CSV), including validation of GxP-relevant software, AI-assisted/low-code/no-code tools, and native-built applications, risk management, supplier/vendor quality, deviation/complaint handling, CAPA, internal auditing, and training. The QA Manager partners cross-functionally to drive a culture of quality, proactive risk management, and continuous improvement.
Primary Responsibilities:
The Quality Assurance Manager provides day-to-day leadership for key Quality Management System (QMS) processes and the Quality team, ensuring continued suitability, compliance, and scalability of the QMS as the business grows. This role is accountable for oversight and effectiveness of change control, Computer System Validation (CSV), including validation of GxP-relevant software, AI-assisted/low-code/no-code tools, and native-built applications, risk management, supplier/vendor quality, deviation/complaint handling, CAPA, internal auditing, and training. The QA Manager partners cross-functionally to drive a culture of quality, proactive risk management, and continuous improvement.
Primary Responsibilities:
Leadership & QMS Governance
  • Lead and develop QA staff through coaching, workload prioritization, performance feedback, and training plans.
  • Own assigned QMS processes end-to-end, ensuring procedures are current, effective, and aligned to applicable FDA/ISO expectations.
  • Promote organizational awareness of the Quality System; deliver and/or coordinate quality training, tools, and best practices.
  • Establish quality objectives and key performance indicators (KPIs); compile, trend, and report quality metrics and corrective actions.
  • Facilitate or contribute to management review inputs (e.g., KPI trends, audit outcomes, CAPA effectiveness, and risk status).

Quality Operations (Change Control, CSV/Validation, Risk, CAPA, Complaints)
  • Provide oversight to change control to ensure appropriate impact assessments, risk evaluations, approvals, implementation, and effectiveness checks.
  • Oversee systems/process validation activities, including Computer System Validation (CSV), to ensure fit-for-purpose controls, compliant documentation, data integrity, and sustainable lifecycle management of regulated and quality-impacting tools.
  • Oversee risk-based CSV activities for GxP-relevant software, spreadsheets, databases, workflow tools, AI-assisted applications, low-code/no-code solutions, and native-built applications, including intended use assessment, risk assessment, traceability, testing, deviation handling, and validation summary reporting.
  • Lead investigations for deviations, nonconformances, and complaints; ensure root cause analyses are rigorous, timely, and appropriately documented.
  • Own or oversee CAPA lifecycle management, including initiation, action planning, implementation, and verification of effectiveness.
  • Engineer solutions to address product, data, and process quality issues; drive continual improvement projects and standardization across teams.

Document Control & Training
  • Ensure document control processes are followed for creation, review, approval, issuance, change, and archival of controlled documents.
  • Support and strengthen the training program: define role-based curricula, coordinate training events, and monitor completion and effectiveness.
  • Maintain and/or oversee maintenance of training records to ensure audit-ready documentation.

Audits & Inspection Readiness
  • Plan and execute internal audits; manage the annual audit program and ensure timely closure of audit findings.
  • Host, co-host, and support client audits; coordinate readiness activities and ensure responses are accurate, complete, and on-time.
  • Conduct or oversee supplier/vendor audits and qualification activities; ensure supplier performance is monitored and issues are escalated and resolved.

Cross-Functional Partnership
  • Partner with Operations, Clinical/Research, Product/Engineering (as applicable), and leadership to integrate quality into daily execution and decision-making.
  • Provide quality guidance during process development, supplier selection/management, and implementation of new tools or workflows, including AI-assisted, low-code/no-code, and native-built applications used in quality or operational processes.
  • Partner with Product/Engineering and business stakeholders to define fit-for-purpose validation controls, change management expectations, and lifecycle oversight for internally developed applications and automation tools.
  • Communicate quality risks clearly to stakeholders; escalate emerging issues and recommend pragmatic, compliant paths forward.

Position Requirements:
  • Bachelor's Degree in Biology, Chemistry, Life Sciences, Engineering, or related field (required).
  • 8+ years of experience in quality supporting clinical research and/or pharmaceutical/biotech development; advanced degree may substitute for a portion of experience.
  • 3+ years of experience leading others (people leadership, team lead, or mentorship/accountability for work output).
  • Demonstrated expertise in QMS processes: change control, deviations/nonconformances, complaints, CAPA, risk management, supplier quality, audits, and training.
  • Demonstrated experience with Computer System Validation (CSV) in a regulated environment, including risk-based validation of software, spreadsheets, SaaS platforms, and workflow tools.
  • Experience validating AI-assisted, low-code/no-code, and native-built applications, with the ability to assess intended use, system risk, testing rigor, data integrity, and change control requirements.
  • Experience compiling and trending quality metrics and driving data-based continuous improvement.
  • Strong working knowledge of FDA and ISO concepts relevant to the organization; ability to interpret requirements and translate them into practical processes.
  • Working knowledge of 21 CFR Part 11, electronic records/electronic signatures expectations, and risk-based validation approaches for digital systems.
  • Regulatory/quality certifications (ASQ/SQA) and/or Lean/Six Sigma (Green Belt/Black Belt) preferred; active continuing education a plus.
  • Strong computer literacy, excellent written and verbal communication skills, and strong organizational/time management skills.
  • Comfortable operating with autonomy, influencing without authority, and making sound quality judgments under time constraints.

Salary: $110,000 to $115,000 annually plus an annual performance based bonus
Sanguine Biosciences is proud to provide equal employment opportunities to all qualified individuals without regard to race, color, religion, sex, gender identity, sexual orientation, pregnancy, age, national origin, physical or mental disability, military or veteran status, genetic information, or any other protected classification. Minorities, women, LGBTQ candidates, Veterans, and individuals with disabilities are encouraged to apply.Sanguine Biosciences is proud to provide equal employment opportunities to all qualified individuals without regard to race, color, religion, sex, gender identity, sexual orientation, pregnancy, age, national origin, physical or mental disability, military or veteran status, genetic information, or any other protected classification. Minorities, women, LGBTQ candidates, Veterans, and individuals with disabilities are encouraged to apply.

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