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Computer System Validation Csv Jobs in California

Trelleborg

Software Validation Engineer

Paso Robles, CA · On-site

$100K - $110K/yr

Provide training, mentorship and guidance on computer system validation, data integrity, and regulatory compliance for CSV. * Stay current with evolving regulatory standards and validation best ...

CREO

Consultant (CSV SAP S/4HANA)

Orange, CA · On-site

This includes Computer Systems Validation (CSV) and, importantly, applying modern approaches to Computer Software Assurance (CSA). * Lead technical discussions, document key compliance decisions, and ...

Alphatec Spine

Senior AI Validation Scientist

Carlsbad, CA · On-site

$130K - $155K/yr

... systems across new product development and sustaining engineering. Under minimal supervision, this ... Prepare and review Computer Software Validation (CSV) documentation per FDA guidance. * Contribute ...

Lonza

Senior Validation Engineer - CSV (OT)

Vacaville, CA · On-site

$93K - $155K/yr

Paid Time Off The Senior Validation Engineer (Computer System Validation) - Operational Technology, at Lonza will be responsible for leading and executing validation activities for manufacturing ...

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How much do computer system validation csv jobs pay per hour?

As of Jun 13, 2026, the average hourly pay for computer system validation csv in California is $51.12, according to ZipRecruiter salary data. Most workers in this role earn between $38.41 and $63.56 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive in the Computer System Validation Csv position, and why are they important?

To thrive as a Computer System Validation (CSV) professional, you need a solid understanding of computer science, regulatory compliance (such as FDA 21 CFR Part 11), and validation methodology, often supported by a degree in a scientific or technical field. Familiarity with documentation tools, validation protocols, and quality management systems, as well as certifications like PMP or Six Sigma, is highly beneficial. Strong attention to detail, problem-solving abilities, and effective communication skills enable effective cross-functional collaboration. Mastering these skills ensures accurate validation processes, regulatory compliance, and smooth project execution in highly regulated environments.

What is a Computer System Validation (CSV) job?

A Computer System Validation (CSV) job involves ensuring that computerized systems used in regulated industries, such as pharmaceuticals and medical devices, comply with industry standards and regulatory requirements (e.g., FDA 21 CFR Part 11, GxP). CSV professionals develop validation protocols, conduct testing, and document system performance to ensure data integrity, reliability, and compliance. Their role is critical in maintaining system quality and avoiding regulatory risks.

What are some typical challenges faced by Computer System Validation professionals and how are they addressed?

Computer System Validation (CSV) professionals often encounter challenges such as keeping up with evolving regulations, managing complex documentation requirements, and ensuring robust communication between IT, quality assurance, and business teams. Navigating system upgrades while maintaining compliance with strict regulatory standards requires careful planning and thorough risk assessment. Successful candidates address these challenges by staying current with industry guidance, utilizing validation templates and checklists, and fostering strong teamwork across various departments. Building collaborative relationships and maintaining meticulous records help ensure both audit readiness and smooth project completion.

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:
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Computer System Validation Csv jobs near you
Infographic showing various Computer System Validation Csv job openings in California as of June 2026, with employment types broken down into 1% Locum Tenens, 37% Full Time, 59% Part Time, 2% Temporary, and 1% Contract. Highlights an 83% Physical, 3% Hybrid, and 14% Remote job distribution, with an average salary of $106,336 per year, or $51.1 per hour.
Manager, Computer Systems Assurance and Validation

Manager, Computer Systems Assurance and Validation

Arrowhead Pharmaceuticals

Los Angeles, CA • On-site

Full-time

Posted 10 days ago

Job description

Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing.

Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.

Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.

The Position

The Manager, Computer Systems Assurance and Validation is a subject matter expert (SME) and project owner responsible for leading and executing computer system validation and assurance activities across the organization. The role drives a risk-based approach to validation through CSA principles and frameworks such as GAMP 5 to ensure GxP systems meet intended use while driving efficiency and compliance with applicable regulatory requirements (e.g., FDA 21 CFR Part 11, EU Annex 11). Acting as a key cross-functional contributor, this individual partners with Quality, IS, Manufacturing, Regulatory, Clinical, and other stakeholders to influence compliance strategy, lead validation initiatives, and actively contribute to the maturation of the company's quality system and validation frameworks. The Manager serves in both an execution and oversight capacity depending on project scope, including signatory responsibilities on validation deliverables, and serves as a key technical voice in shaping how the organization approaches validation in a regulated GxP environment.

This role is base onsite 5x a week at Arrowhead's Corporate Headquarters in Pasadena, CA.

Responsibilities

Compliance Strategy & SME Leadership

  • Collaborate with Quality Assurance and IS leaders to support the development and implementation of risk-based CSA/CSV strategies and frameworks (CSA, GAMP 5) ensuring alignment with global regulatory requirements and industry best practices.
  • Drive the adoption of CSA principles for validation projects, facilitating the shift from traditional CSV approaches toward risk-based methodologies that reduce unnecessary documentation while maintaining compliance.
  • Serve as subject matter expert (SME) on validation and compliance topics, advising internal stakeholders on best practices for software validation and assurance.
  • Maintain awareness of evolving regulatory expectations and support updates to company policies and procedures accordingly.
  • Partner with Quality and cross-functional teams to develop, refine, and mature validation processes, quality systems, and frameworks, ensuring they are scalable, audit-ready, and aligned with current and emerging regulatory expectations.

Validation & Assurance Activities

  • Partner with System Owners to own and execute the full validation lifecycle for GxP systems, including planning, risk assessment, testing, reporting, and periodic review, applying a risk-based approach throughout.
  • Execute and/or oversee validation activities depending on project scope and complexity, including serving as a signatory on validation deliverables where appropriate.
  • Author validation deliverables (e.g., system requirements, validation plans, URS, test scripts, traceability matrices, validation reports) in accordance with regulatory expectations and internal standards.
  • Apply risk-based testing strategies to optimize validation efforts and focus resources on areas of greatest compliance impact.
  • Lead ongoing system assurance activities including periodic reviews, change management, and system decommissioning.

Requirements

  • Bachelor's degree in Computer Science, Information Systems, Life Sciences, Engineering, or a related field.
  • 8+ years of experience in CSV/CSA within the pharmaceutical, biotechnology, or medical device industry.
  • Solid understanding of regulatory requirements (e.g., FDA 21 CFR Part 11, EU Annex 11, GAMP 5, ICH guidelines).
  • Demonstrated experience applying a risk-based approach to validation, including CSA principles and GAMP 5 frameworks.
  • Proven ability to lead validation projects and serve as a cross-functional SME and collaborative partner.
  • Strong communication, influence, and problem-solving skills; operates with a high degree of independence and a proactive, ownership-oriented mindset.

Preferred

  • Advanced degree in a relevant field.
  • Experience with validation of both pure software systems (e.g., SaaS, cloud-based applications) and equipment with embedded or integrated software components (e.g., lab instruments, manufacturing equipment).
  • Experience contributing to the development or improvement of quality processes, quality systems, SOPs, or validation frameworks in a regulated environment.
  • Experience working with Quality Management Systems (QMS) and electronic validation tools.
  • Experience supporting regulatory inspections and audits.
California pay range
$130,000—$150,000 USD

Arrowhead provides competitive salaries and an excellent benefit package.

Candidates must have current, valid authorization to work in the country where this role is located.

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