Talent.com
Katalyst HealthCares & Life Sciences
Computer System Validation EngineerKatalyst HealthCares & Life Sciences • Vacaville, CA
Computer System Validation Engineer

Computer System Validation Engineer

Katalyst HealthCares & Life Sciences • Vacaville, CA
30+ days ago
Job type
  • Full-time
Job description

Job Summary:
  • As a Computer System Validation (CSV) Engineer in the pharmaceutical industry, this role is responsible for ensuring that computer-based systems such as Manufacturing Execution Systems (MES), process control software, and automation platforms comply with GxP, FDA CFR Part , EU Annex , and other applicable regulatory requirements.

Roles & Responsibilities:
  • Develop, execute, and review validation deliverables, including Validation Plans, User Requirements Specifications (URS), IQ/OQ/PQ protocols, and Summary Reports.
  • Collaborate with Quality Assurance, IT, Engineering, and Production teams to ensure system compliance and data integrity.
  • Support internal audits and inspections, ensuring readiness and adherence to regulatory expectations.
  • Provide training to stakeholders on validation requirements and best practices.
  • Maintain validation lifecycle documentation and change control records .

Education & Experience:
  • Experience with Computer System Validation (CSV) in a regulated pharmaceutical or biotech environment.
  • Strong knowledge of GxP, FDA CFR Part , and EU Annex .
  • Proficiency in authoring and executing validation documentation.

Create a job alert for this search

Computer System Validation Engineer • Vacaville, CA

Similar jobs

Looking for Senior Cloud Engineer || Concord, CA (Onsite)

TechnoGen IncConcord, CA, US
Full-time

Proven Leader in providing full IT Services, Software Development and Solutions for 15 years.TECHNOGEN is a Small and Woman Owned Minority Business with GSA Advantage Certification.We have offices ... Show more

 • Promoted

Software Architect – Wind River Orchestration and Automation Platform

Wind RiverWalnut Creek, CA, US
Full-time

Software Architect – Wind River Orchestration and Automation Platform.Wind River is a global leader in delivering software for mission-critical intelligent systems.We power billions of systems that... Show more

 • Promoted

Travel CT Tech - $2,556 to $2,756 per week in Vacaville, CA

AlliedTravelCareersVacaville, CA, US
$2,556.00 weekly
Full-time

AlliedTravelCareers is working with Titan Medical Group to find a qualified CT Tech in Vacaville, California, 95687!.BCLS/BLS - American Heart Association/ARRT(CT).Titan Medical is looking for trav... Show more

 • Promoted

Full Time Associate Veterinarian

Lap of LoveWinters, CA, US
Full-time

Live Your Best Life at Lap of Love Veterinary Hospice!.Join Lap of Love as an In-Home, Associate Veterinarian in Sacramento, CA and surrounding areas.Imagine a veterinary role that honors your time... Show more

 • Promoted

Medical Billing and Coding - Entry Level Training Program

DreamboundFairfield, California, United States
Full-time

Note : This is an educational program, not a job.Successful completion of the program does not guarantee employment but will equip you with valuable skills for the healthcare job market.Looking to ... Show more

 • Promoted

Infrastructure Engineer - Vacavile,CA

Unicon Pharma IncVacaville, CA, United States
Full-time
Quick Apply

Description:</b></p> <p align="left" style="text-align:left"><b>Scope:</b></p> <ul> <li align="left" style="text-alig... Show more

Travel CT Tech - $2,926 per week in Fairfield, CA

AlliedTravelCareersFairfield, CA, US
$2,926.00 weekly
Full-time

AlliedTravelCareers is working with talent4health to find a qualified CT Tech in Fairfield, California, 94533!.Talent4Health is the most candidate-centric agency in the industry.Talent4Health has c... Show more

 • Promoted

Cardiology Non-Invasive in Vallejo

The Permanente Medical Group, Inc. - N.CaliforniaElmira, CA, US
Full-time

Kaiser Permanente/The Permanente Medical Group, Inc.Leading the Future of Health Care.Cardiology - Non-Invasive in Vallejo, CA.BE/BC Non-Invasive Cardiologist to join our team in.The Permanente Med... Show more

 • Promoted

Automation Systems Engineer – Manufacturing & QC Systems

Unicon Pharma IncVacaville, CA, United States
Full-time

Provide support and technical contribution for the Process Automation Systems Distributed Control System (DCS), Manufacturing Control System (MCS), Programmable Logic Controllers (PLC), Building Au... Show more

 • Promoted

Engineer

Sunrise SystemsVacaville, California, United States
Full-time
Quick Apply

These positions will be half in Vacaville, CA and half in Rocklin, CA.Months (Possible Extension or Conversion).LOCAL CANDIDATES ONLY** Hybrid role.The roles will be onsite once per week and the re... Show more

SALES REP -VACAVILLE COSTCO

Direct Demo LLCVacaville, CA, US
$24.00 hourly
Part-time
Quick Apply

WE’RE HIRING SALES REPS – VACAVILLE COSTCO If you love selling, this is where you turn a part-time role into serious earnings.We’re looking for high-energy, outgoing salespeople t... Show more

Squadron Standardization / Evaluation EFB Coordinator

INTECONTravis Afb, CA, United States
Permanent

Squadron Standardization / Evaluation EFB Coordinator, Senior II/h2pINTECON is seeking a Squadron Stan/Eval EFB Coordinator to support Air Mobility Command (AMC) flying squadrons by maintaining air... Show more

 • Promoted

Systems Engineer

EUV TechMartinez, California, United States, 94553
$135,000.00 yearly
Full-time
Quick Apply

Candidates often screen themselves out of job applications if they do not meet all the qualifications.So, please apply if you're excited about a role at EUV Tech—we would love to see your applicati... Show more

Travel CT Tech - $2,886 per week in Fairfield, CA

AlliedTravelCareersFairfield, CA, US
$2,886.00 weekly
Full-time

AlliedTravelCareers is working with Cynet Health to find a qualified CT Tech in Fairfield, California, 94533!.Job Title: CT Technologist Profession: Tech Specialty: CT Duration: 8 weeks Shi... Show more

 • Promoted

Advanced Electronics / Computer Field Technician

US NavyEsparto, CA, US
Full-time

Advanced Electronics / Computer Field (ET/FC).The Advanced Electronics and Computer Field trains Sailors to maintain, operate, and repair some of the Navy’s most sophisticated electronics and compu... Show more

 • Promoted

Automation Systems Engineer

TekWissen LLCVacaville, CA, United States
Full-time
Quick Apply

Overview: </b> </div> <div style="text-align: justify;"> </div> <div style="text-align: justify;">TekWissen is a global workforce management prov... Show more

Firmware FPGA Engineer

Emcore CorporationConcord, CA, USA
$130,000.00 yearly
Full-time
Quick Apply

At EMCORE, we're committed to attracting and nurturing diverse, high-performing talent who are passionate about their work.Our employees share a common purpose-supporting our customers' missions wh... Show more

IT Support Engineer

XantrionLafayette, CA, US
$60,000.00 yearly
Full-time
Quick Apply

IT Support Engineer 1 - Hybrid (Foster City) This is a hybrid position that requires traveling to and working at client locations 2 days a week in Foster City.At least 1 day a week a... Show more

AI Software Engineer (Fullstack)

ClearstoryWalnut Creek, CA, US
Full-time
Quick Apply

Clearstory is hiring an AI Agent Engineer (Fullstack) to help build the next generation of intelligent automation across our platform.AI agents are becoming core to how Clearstory delivers value — ... Show more

Billing and Coding Supervisor - FULLY REMOTE

Balance HealthConcord, CA, United States
Remote
Full-time

Job DescriptionJob DescriptionDescription:POSITION Summary:Supports daily billing and coding operations by coordinating workflows, monitoring productivity and ensuring accuracy, compliance, and tim... Show more