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Computer Systems Validation Jobs in Irvine, CA (NOW HIRING)

Description Join our Wireless Systems Design Validation Team, where we ensure cutting-edge wireless ... Preferred Qualifications Advanced degree in Electrical Engineering or Computer Engineering; Master ...

Description Join our Wireless Systems Design Validation Team, where we ensure cutting-edge wireless ... Preferred Qualifications Advanced degree in Electrical Engineering or Computer Engineering; Master ...

Description Join our Wireless Systems Design Validation Team, where we ensure cutting-edge wireless ... Preferred Qualifications Advanced degree in Electrical Engineering or Computer Engineering; Master ...

Description Join our Wireless Systems Design Validation Team, where we ensure cutting-edge wireless ... Preferred Qualifications Advanced degree in Electrical Engineering or Computer Engineering; Master ...

Description Join our Wireless Systems Design Validation Team, where we ensure cutting-edge wireless ... Preferred Qualifications Advanced degree in Electrical Engineering or Computer Engineering; Master ...

Description Join our Wireless Systems Design Validation Team, where we ensure cutting-edge wireless ... Preferred Qualifications Advanced degree in Electrical Engineering or Computer Engineering; Master ...

Description Join our Wireless Systems Design Validation Team, where we ensure cutting-edge wireless ... Preferred Qualifications Advanced degree in Electrical Engineering or Computer Engineering; Master ...

Description Join our Wireless Systems Design Validation Team, where we ensure cutting-edge wireless ... Preferred Qualifications Advanced degree in Electrical Engineering or Computer Engineering; Master ...

Basic experience with equipment cleaning and computer systems validation methodologies is a plus. * Experience in electronic validation systems is preferred but not required. * Openness to learning ...

Basic experience with equipment cleaning and computer systems validation methodologies is a plus. * Experience in electronic validation systems is preferred but not required. * Openness to learning ...

Basic experience with equipment cleaning and computer systems validation methodologies is a plus. * Experience in electronic validation systems is preferred but not required. * Openness to learning ...

Collaborate closely with platform software teams, application developers, systems engineers, and ... Bachelor's degree (or foreign equivalent) in Computer Science, Computer Engineering or related ...

CSV Engineer

Costa Mesa, CA ยท On-site

$55 - $60/hr

Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field. * 2-10+ years of experience in computerized systems validation within pharmaceutical, biotechnology, or life ...

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Computer Systems Validation information

See Irvine, CA salary details

$11

$58

$92

How much do computer systems validation jobs pay per hour?

As of Jul 26, 2026, the average hourly pay for computer systems validation in Irvine, CA is $58.31, according to ZipRecruiter salary data. Most workers in this role earn between $44.90 and $69.13 per hour, depending on experience, location, and employer.

What is the work of computer system validation?

Computer Systems Validation (CSV) is the process of ensuring that computer systems used in regulated environments function correctly and comply with industry standards. It involves documenting and testing software, hardware, and related processes to verify they meet specified requirements, often using validation protocols and tools. CSV helps maintain data integrity, quality, and regulatory compliance in industries like pharmaceuticals and healthcare.

What is the salary of a CSV engineer?

A Computer Systems Validation (CSV) engineer's salary typically ranges from $70,000 to $120,000 annually, depending on experience, location, and industry. Certifications in validation or quality assurance and proficiency with regulatory standards like FDA or GxP can influence compensation levels.

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

To thrive in Computer Systems Validation, you need a solid understanding of regulatory requirements (such as FDA or EMA guidelines), software development life cycles, and risk management, often supported by a degree in life sciences, IT, or engineering. Experience with validation frameworks, documentation tools, and systems like GAMP 5 and knowledge of 21 CFR Part 11 compliance are typically required. Attention to detail, strong analytical thinking, and effective communication set professionals apart in this role. These skills and qualifications ensure validated systems are compliant, reliable, and support organizational quality and regulatory objectives.

Is computer system validation a good field?

Computer Systems Validation (CSV) is a vital role in regulated industries like pharmaceuticals and biotech, ensuring that computer systems meet quality and compliance standards. It involves skills in validation protocols, documentation, and understanding regulatory requirements such as FDA or EMA guidelines. The field offers steady employment opportunities, especially for professionals with certifications like GAMP or 21 CFR Part 11 knowledge.

What is the difference between Computer Systems Validation vs Quality Assurance Specialist?

AspectComputer Systems ValidationQuality Assurance Specialist
CertificationsGAMP, CSV-specific trainingISO 9001, Six Sigma
Work EnvironmentRegulated industries like pharma, biotechManufacturing, software, service sectors
Primary FocusEnsuring computer systems meet regulatory standardsEnsuring overall product/service quality
Common UsageValidation of software, hardware in complianceProcess audits, quality improvement

Computer Systems Validation and Quality Assurance Specialist roles overlap in ensuring compliance and quality. However, CSV focuses specifically on validating computer systems to meet regulatory standards, especially in pharma and biotech industries. Quality Assurance Specialists have a broader scope, overseeing overall quality processes across various sectors. Both roles require similar certifications and work environments but differ in their primary objectives and specific tasks.

What is computer systems validation?

Computer systems validation (CSV) is the process of ensuring that computer-based systems used in regulated industries, like pharmaceuticals and biotechnology, perform their intended functions consistently and reliably. This process involves documenting and testing systems to confirm they meet regulatory requirements, such as those set by the FDA. The goal is to ensure data integrity, product quality, and patient safety by minimizing the risk of system errors or failures. CSV typically includes activities like risk assessment, test planning, execution, and maintaining thorough records for audits.

What is the salary of SoC validation engineer?

The salary of a SoC validation engineer typically ranges from $80,000 to $130,000 annually, depending on experience, location, and company size. Professionals in this role often have skills in hardware description languages and verification tools such as SystemVerilog and UVM.

What are some common challenges faced in a Computer Systems Validation (CSV) role, and how can they be addressed?

Professionals in Computer Systems Validation often encounter challenges such as keeping up with evolving regulatory requirements, managing documentation for multiple systems, and coordinating with cross-functional teams. Staying updated through regular training and industry resources helps address compliance changes. Clear communication and collaboration with IT, Quality Assurance, and business stakeholders are essential for efficient validation processes. Utilizing validation lifecycle management tools and standardized templates can also streamline documentation and reduce errors.
What are popular job titles related to Computer Systems Validation jobs in Irvine, CA? For Computer Systems Validation jobs in Irvine, CA, the most frequently searched job titles are:
What job categories do people searching Computer Systems Validation jobs in Irvine, CA look for? The top searched job categories for Computer Systems Validation jobs in Irvine, CA are:
What cities near Irvine, CA are hiring for Computer Systems Validation jobs? Cities near Irvine, CA with the most Computer Systems Validation job openings:
Infographic showing various Computer Systems Validation job openings in Irvine, CA as of July 2026, with employment types broken down into 1% As Needed, 81% Full Time, 15% Part Time, and 3% Contract. Highlights an 93% Physical, 2% Hybrid, and 5% Remote job distribution, with an average salary of $121,275 per year, or $58.3 per hour.
Computer System Validation Engineer

Computer System Validation Engineer

Avid Bioservices

Tustin, CA โ€ข On-site

$82K - $104K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 8 days ago


Job description

Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.
Your Role:
The Computer System Validation Engineeris responsible for providing technical validation support for manufacturing equipment, laboratory instruments, computer systems, networks, and software that have been newly installed, upgraded, replaced and/or modified in the cGMP Manufacturing Facility as well as its related manufacturing support areas, which may include Facilities/ Engineering, Quality Assurance, Supply Chain, and Quality Control.
  • Review and help author User Requirement Specification (URS) and/or Requirement Specification documents for manufacturing equipment/systems and processes
  • Generate and execute Installation, Operational and Performance/Process qualification (IQ, OQ, PQ) protocols, engineering studies and final reports thatcomply with corporate and regulatory requirements.
  • Coordinate and oversee validation protocol execution or validation activities with cross-functional departments.
  • Evaluate and analyze qualification data collected during projects, while verifying acceptability of the data and compliance with the approved protocol.
  • Ensure any deviations to protocols and/or deviations to acceptance criteria are adequately addressed, documented and reviewed by the Validation Committee
  • Provide input and assist on the development of validation policies and procedures.
  • Effectively interact and provide validation guidance to other departments.
  • Assist department manager in developing realistic time and resource requirements for validation activities in support of company expectation.
  • Provide input and assist in change control assessment and Part 11 assessment for validated systems.
  • Review Standard Operating Procedures (SOPs) and ensure the operational parameters described in the SOP for the equipment reflects validated conditions.
  • Assist department manager on other types of projects/managerial responsibilities as needed
Minimum Qualifications:
  • BA/BS in science (such as Biology, Microbiology, Biochemistry, Chemistry), Engineering (such as Electrical, Electronics, Computer Science) or other equivalent technology related field.
  • Minimum of 3 years' work experience in biopharmaceutical/pharmaceutical manufacturing environment of which 1 year is directly involved in validations.
Position Type/Expected Hours of Work:
This role is a full-time position. Days and hours of work are Monday through Friday, 8am to 5pm PST, unless otherwise stated by Supervisor.
Compensation:
We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
The compensation range for this role is $82,000- $104,400 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.
Who you are:
  • You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
  • Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
  • You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
  • You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Physical Demands & Work Environment:
In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
Employment Type: Full-Time