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Computer networking • vacaville ca

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Computer System Validation Engineer

Computer System Validation Engineer

CAIVacaville, California, United States, 95687
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CAI is a 100% employee-owned professional services company established in 1996 that has grown to more than 700 people worldwide. We provide commissioning, qualification, validation, startup, project...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
NON-COMPACT STATE - PT Remote CCM / RTM Care Management Nurse (CA)

NON-COMPACT STATE - PT Remote CCM / RTM Care Management Nurse (CA)

Harris ComputerRemote, CA
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Join our mission to help transform healthcare delivery from reactive, episodic care to proactively managed patient care that prevents live-changing problems before they happen for patients with two...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Computer Engineer

Computer Engineer

EHA DHATravis Afb, CA, United States
serp_jobs.job_card.full_time +3
Click on "Learn more about this agency" button below for.This is a Direct Hire Solicitation.This public notice is to gather applications that may or may not result in a referral or selection.Duties...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Senior Solutions Architect, Networking

Senior Solutions Architect, Networking

NVIDIARemote, CA, US
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As a key member of the NVIDIA Professional Services Solution Architecture team, your role involves spearheading the conception, development, and execution of cutting-edge data center networks for N...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
COMPUTER SCIENCE

COMPUTER SCIENCE

Santa Rosa Junior CollegeSonoma County, CA
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Santa Rosa Junior College is currently accepting applications to establish a pool for part-time associate faculty assignments. Associate assignments are temporary, part-time or on-call.This job post...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Computer System Validation Engineer

Computer System Validation Engineer

CAIVacaville, California, United States, 95687
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  • serp_jobs.job_card.full_time
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Are You Ready?

CAI is a 100% employee-owned professional services company established in 1996 that has grown to more than 700 people worldwide. We provide commissioning, qualification, validation, startup, project management, and other consulting services associated with operational readiness to FDA-regulated and other mission-critical industries.

Our approach is simple—we put the client’s interests first, we don’t stop until it’s right, and we do whatever it takes to get there.

Our Foundational Principles :

  • We act with integrity
  • We serve each other
  • We serve society
  • We work for our future

With employee ownership, one person’s success is everyone’s success. We work diligently to accomplish team goals and live our core values :

  • Team Before Self
  • Respect for Others
  • Can-Do Attitude

    • Key Responsibilities

    Documentation & Compliance

  • Author GxP computer validation documentation (e.g., URS, FRS, RTM, summary reports)
  • Generate and execute test protocols and scripts
  • Ensure adherence to 21 CFR Part 11 and data integrity principles
  • Review and contribute to validation plans and risk assessments

    • System & Industry Expertise

  • Support CSV activities across various platforms including MES, DCS, SCADA, and batch systems
  • Engage with major systems and platforms such as Rockwell PharmaSuite, Emerson Syncade, DeltaV, PI, GE, ABB, Siemens,

    • Honeywell, PAS-X, FactoryTalk, FactoryLogix, PLM, Simatic, iFix, Wonderware

  • Apply knowledge of GAMP and compliance expectations (21 CFR Parts 210, 211, 11)
  • Utilize familiarity with S88 / S95 batch control standards

    • Client Support & Technical Execution

  • Support client engagements with strong customer-service orientation
  • Perform system assessments and remediation related to data integrity
  • Collaborate with client teams to ensure validation compliance and delivery

    • Qualifications and Experience

  • Bachelor’s degree (BS / BA) in Computer Science, Engineering, or related field; equivalent experience may be accepted
  • Minimum of 3+ years of experience in computer systems validation
  • Experience in biotech or pharmaceutical environments preferred over medical device
  • In-depth understanding of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211)
  • Familiarity with S88 / S95 batch control standards
  • Experience with multiple automation and manufacturing execution systems is highly desirable
  • Data integrity assessment / remediation experience is a plus

    • Other Requirements

  • Excellent oral and written communication skills in English
  • Ability to travel domestically and internationally as required
  • Willingness to work paid overtime when needed
  • Must be authorized to work in the U.S. without current or future sponsorship

    • Critical Competencies

    Influence Strategy

  • Pursues opportunities based on organizational fit and strategy
  • Identifies high-impact, innovative solutions

    • Satisfy the Customer

  • Anticipates and meets client needs
  • Delivers high-quality solutions and maintains satisfaction

    • Plan for Success

  • Aligns business goals with execution plans
  • Allocates resources and builds risk mitigation strategies

    • Pursue Execution

  • Prioritizes effectively and ensures accountability
  • Proactively addresses challenges

    • Tailor Communication

  • Communicates clearly and professionally
  • Adapts style for technical and non-technical audiences

    • Build Partnerships

  • Builds cross-functional networks
  • Promotes collaboration and stakeholder engagement

    • Influence Others

  • Gains support through sound reasoning
  • Promotes innovation and value

    • Develop Self and Others

  • Demonstrates integrity and commitment to growth
  • Builds effective relationships internally and externally

    • LI-MV1

    Average base salary range - not including benefits, and potential overtime and / or Cost of Living Adjustment.

    Benefits

    Competitive compensation

    Up to 15% retirement contribution

    24 days PTO + 5 sick days annually

    Low-cost health insurance for employees

    70% long-term disability coverage paid by the company

    Financial support for internal / external education and certifications

    We are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all – our employees, our customers, and the broader society.

    This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO).

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