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Computer System Validation Engineer Jobs in Vacaville, CA

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 ...

Grifols

Manufacturing Digital Manager

Clayton, CA

Act as the liaison between Engineering/Maintenance and IT to ensure systems, reports, and processes ... Strong experience with data integrity principles, computer system validation (CSV), and GxP ...

E Tech Group

Senior Controls Engineer

Sonoma, CA · On-site

$90K - $130K/yr

We're one of the largest engineering and system integration firms in the United States providing ... Control system validation experience of pharmaceutical/biotech systems a plus * Other PLC platform ...

E Tech Group

Senior Controls Engineer

Sonoma, CA · On-site

$90K - $130K/yr

We're one of the largest engineering and system integration firms in the United States providing ... Control system validation experience of pharmaceutical/biotech systems a plus * Other PLC platform ...

E Tech Group

Senior Controls Engineer

Sonoma, CA · On-site

$90K - $130K/yr

We're one of the largest engineering and system integration firms in the United States providing ... Control system validation experience of pharmaceutical/biotech systems a plus * Other PLC platform ...

Talnt

Manufacturing Process Engineer

Woodland, CA

$150K - $160K/yr

This role is responsible for developing, validating, optimizing, and sustaining manufacturing ... Proficiency with SolidWorks, AutoCAD, or similar CAD software. * Strong understanding of tooling ...

Aptiv

System Engineer - OS Kernel

Walnut Creek, CA · On-site

$100K - $135K/yr

System Engineer - OS Kernel Location: Walnut Creek, CA ABOUT WIND RIVER Wind River is a global ... Contribute to coding, testing, and validation following a CI/CD model and agile methodology ...

Aptiv PLC

System Engineer - OS Kernel

Walnut Creek, CA · On-site

$100K - $135K/yr

System Engineer - OS Kernel Location: Walnut Creek, CA ABOUT WIND RIVER Wind River is a global ... Contribute to coding, testing, and validation following a CI/CD model and agile methodology ...

Keish Environmental

Office Engineer

Concord, CA · On-site

$90K - $130K/yr

Valid Construction General Permit Qualified SWPPP Practitioner (QSP) and/or Developer (QSD ... MEP systems. * Ability to: Detect poor quality materials/workmanship, read and interpret plans ...

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All JobsComputer System Validation Engineer JobsComputer System Validation Engineer Jobs in Vacaville, CA

Computer System Validation Engineer information

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

As of Aug 15, 2026, the average hourly pay for computer system validation engineer in Vacaville, CA is $58.68, according to ZipRecruiter salary data. Most workers in this role earn between $44.13 and $72.98 per hour, depending on experience, location, and employer.

What are some common challenges faced by computer system validation engineers in regulated industries?

Computer System Validation Engineers often encounter challenges such as keeping up with evolving regulatory requirements, managing documentation for multiple systems, and ensuring timely validation while coordinating with cross-functional teams. Balancing strict compliance with project deadlines can be demanding, especially when systems are complex or legacy infrastructure is involved. Additionally, effective communication with IT, QA, and business stakeholders is essential to address issues quickly and maintain validation standards.

Are computer system validation engineers in demand?

Computer System Validation Engineers are in demand due to the increasing regulation of pharmaceutical, biotech, and medical device industries that require compliant validation of computer systems. They often need skills in validation protocols, GxP regulations, and validation tools, making their expertise valuable in ensuring quality and compliance in regulated environments.

What does a computer system validation engineer do?

A computer system validation engineer ensures that computer systems used in regulated industries, such as pharmaceuticals or biotech, meet required standards for quality and compliance. They develop validation protocols, execute testing, and document results to verify systems function correctly and consistently. This role often involves working with validation tools, regulatory guidelines, and maintaining detailed records to support audits and inspections.

What are the key skills and qualifications needed to thrive as a computer system validation engineer?

To thrive as a Computer System Validation Engineer, you need a solid background in computer science or engineering, knowledge of regulatory requirements (such as FDA or GxP), and experience in validation processes. Familiarity with validation tools, quality management systems, and documentation software is typically required, along with certifications like ISPE or ASQ being beneficial. Strong attention to detail, analytical thinking, and effective communication are essential soft skills for coordinating teams and ensuring compliance. These skills and qualities are crucial to ensure that computer systems meet regulatory standards, maintain data integrity, and support business operations in regulated industries.

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

AspectComputer System Validation EngineerQuality Assurance Specialist
CertificationsGAMP, GxP validation certificationsISO, Six Sigma, GMP certifications
Work EnvironmentPharmaceutical, biotech, medical device industriesManufacturing, software, healthcare sectors
Primary FocusValidating computer systems and software complianceEnsuring overall quality and process improvements

The Computer System Validation Engineer primarily focuses on validating computer systems to meet regulatory standards, ensuring software compliance in regulated industries. In contrast, the Quality Assurance Specialist oversees broader quality processes, including audits and process improvements. Both roles require knowledge of industry regulations but differ in scope and specific responsibilities.

Do computer system validation engineers make good money?

Computer System Validation Engineers typically earn competitive salaries that vary by experience, location, and industry. They often have specialized skills in validation protocols, regulatory compliance, and validation tools, which can contribute to higher earning potential. Overall, this role is considered well-compensated within the pharmaceutical, biotech, and healthcare sectors.

Is computer system validation a good field?

Computer System Validation (CSV) is a vital part of regulated industries like pharmaceuticals and biotech, ensuring that computer systems meet quality and compliance standards. It offers opportunities for roles such as validation engineers, often requiring knowledge of GxP regulations, validation protocols, and tools like audit trails. The field provides stable employment with potential for career growth, especially with certifications like GAMP or 21 CFR Part 11 knowledge.

What job categories do people searching Computer System Validation Engineer jobs in Vacaville, CA look for?

The top searched job categories for Computer System Validation Engineer jobs in Vacaville, CA are:

What cities near Vacaville, CA are hiring for Computer System Validation Engineer jobs?

Cities near Vacaville, CA with the most Computer System Validation Engineer job openings:

Computer System Validation Engineer jobs near you
Infographic showing various Computer System Validation Engineer job openings in Vacaville, CA as of August 2026, with employment types broken down into 1% As Needed, 74% Full Time, 23% Part Time, and 2% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $122,058 per year, or $58.7 per hour.

IT Portfolio & Project Manager

Cerus

Concord, CA • On-site

$108K - $127K/yr

Full-time

Medical, Dental, Vision, Life, Retirement

Re-posted yesterday

Job description

About Cerus:
Cerus aims to be the global leader and trusted partner of blood centers and hospitals whose technology, services, and commitment are the lifeblood of safe and accessible blood for patients around the world.
This is a hybrid role requiring two days per week in our Concord, CA office.
Position Summary
Cerus is seeking a hands-on IT Portfolio & Project Manager to bring structure, visibility, and execution rigor to how IT work is requested, evaluated, prioritized, approved, tracked, and communicated. This role will serve as the initial "PMO-of-one," building foundational project intake and governance practices while directly managing and delivering IT projects end-to-end. The successful candidate will reduce reliance on technical SMEs as ad-hoc project managers, improve strategic alignment and decision-making, and increase delivery predictability - while ensuring IT projects and computerized systems meet applicable regulatory and validation requirements.
Key Responsibilities
Portfolio Intake, Triage, and Prioritization
  • Establish and manage a single front door for IT demand (intake forms, triage workflow, and centralized backlog).
  • Develop and maintain simple definitions and thresholds to classify work (request vs enhancement vs project) and apply the appropriate level of governance.
  • Partner with IT leadership and business stakeholders to implement a lightweight prioritization approach (scoring for strategic alignment, urgency, risk, effort).
  • Facilitate regular portfolio review meetings to drive clear outcomes: approve, defer, reject, or request discovery and with decisions captured and communicated.

Stakeholder, Cross-Functional, and Vendor Collaboration
  • Serve as the primary point of contact between IT, business stakeholders, and vendors for assigned projects and portfolio initiatives.
  • Translate business needs into actionable requirements, project charters, and delivery plans in partnership with IT SMEs and functional owners.
  • Facilitate project status meetings and communicate progress, risks, dependencies, and decisions to stakeholders and leadership.
  • Proactively manage expectations, align on scope and outcomes, and drive timely decisions and issue resolution.

Project Delivery (Hands-On Execution)
  • Directly manage and deliver IT projects (systems implementations, infrastructure initiatives, cybersecurity/compliance projects, process improvements) from intake through closeout.
  • Lead project planning activities: scope definition, milestones, stakeholder alignment, communications, and implementation planning.
  • Drive execution discipline: weekly status, issue/risk management, dependency tracking, change control, and escalation.
  • Coordinate cross-functional delivery teams so SMEs can focus on technical execution while you manage planning, coordination, and stakeholder alignment.

Computer System Validation (CSV) and Regulatory Compliance
  • Coordinate and support Computer System Validation (CSV) activities, including validation planning, execution, and documentation, in alignment with company procedures.
  • Ensure IT systems and project deliverables comply with applicable regulations and standards (FDA 21 CFR Part 11, ISO 13485, and GxP where applicable).
  • Incorporate CSV, SDLC controls, and regulatory requirements into project plans, timelines, and deliverables (requirements, risk assessments, traceability, testing, approvals, and evidence packages).
  • Collaborate with stakeholders and system owners to address data integrity, cybersecurity considerations, and validation expectations for computerized systems.

Governance, Reporting, and Communication
  • Build and run an IT project governance cadence (weekly/biweekly) that provides visibility into status, risks, dependencies, and decisions needed.
  • Maintain an auditable decision log and ensure stakeholders understand tradeoffs, scope impacts, and sequencing.
  • Produce executive-ready portfolio dashboards and summaries.
  • Standardize project documentation and templates

Financial and Vendor Management
  • Implement a practical approach to project financial tracking starting with vendor/SOW costs (quotes, POs, invoices) plus rough internal effort estimates to support forecasting and tradeoffs.
  • Track forecast vs actual costs for project work and highlight variances, risks, and decision points.
  • Coordinate vendor milestones/deliverables and ensure invoicing aligns to outcomes.

Continuous Improvement and Enablement
  • Identify bottlenecks, propose improvements, and evolve governance based on feedback and adoption.
  • Coach and enable IT staff on consistent project practices (templates, reporting rhythm, role clarity).
  • Contribute to an IT roadmap view by linking demand and projects to business priorities and compliance/security needs.

Required Qualifications
  • Bachelor's degree in Information Systems, Business, Project Management, or equivalent experience.
  • 5+ years of IT project management experience in a regulated environment (medical devices, pharma, biotech, healthcare).
  • Strong understanding of CSV, SDLC, and regulatory requirements for computerized systems.
  • Familiarity with data integrity, cybersecurity, and FDA 21 CFR Part 11 compliance concepts.
  • Demonstrated experience establishing or improving project processes (intake, governance, reporting) in an environment with limited prior structure.
  • Strong ability to communicate project status and issues clearly to both technical and non-technical audiences.

Preferred Qualifications
  • Hands-on experience supporting or leading Computer System Validation (CSV) for enterprise applications and/or infrastructure supporting regulated processes.
  • Familiarity with FDA, ISO (including ISO 13485), and GxP regulations/expectations.
  • Experience coordinating vendor-led projects and managing SOW-based delivery.
  • Project management certification (PMP, CAPM, PMI-ACP, Scrum Master) is a plus but not required.

Core Competencies
  • Builder + Doer mindset: creates structure while actively delivering projects.
  • Execution rigor: anticipates risks, manages dependencies, and drives closure.
  • Facilitation and influence: aligns stakeholders, resolves conflict, and drives decisions.
  • Clear communication: concise, consistent, transparent reporting; strong written documentation.
  • Compliance-minded delivery: embeds CSV/SDLC controls and evidence expectations into plans and execution.

We understand that our people are essential to our success. This philosophy is revealed in our competitive benefits package, designed to improve employees' lives both on and off the job.
Benefits plans: medical, dental, vision, domestic partner benefits, paid maternity and paternity leaves, healthcare and dependent care flexible spending, life and accidental death insurance, long-term and short-term disability insurance, matching 401(k), RSUs
Work and family: EAP, legal and financial services, health club membership discounts, tuition reimbursement
Compensation: The base salary range for this position in the selected city is $144,000-$174,000 annually. Base pay is one part of the total package to compensate and recognize employees for their work.
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.
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About Cerus

Sourced by ZipRecruiter

Industry

Biotechnology research and development

Company size

201 - 500 Employees

Headquarters location

Concord, CA, US

Year founded

1991

Social media

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