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

SRE /System Engineer - Skan AI

VSG Business Solutions LLCConcord, CA, United States
Full-time
Quick Apply

Responsibilities:</b></p> <p> Deployment Planning & Coordination: Lead end-to-end customer Gateway</p> <p>deployments - from strategic planning and infrastructu... Show more

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

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

Medical Billing and Coding - Entry Level Training Program

DreamboundSuisun City, 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

Validation Engineer

SPECTRAFORCEVacaville, CA, United States
Full-time

M-F 8am - 4pm (including unpaid lunch 30 mins).With direct supervision, candidate is responsible for support and execution of QC laboratory equipment qualification activities while in full complian... Show more

 • Promoted • New!

Cloud HPC Engineer

Mat3raWalnut Creek, CA, US
$130,000.00 yearly
Full-time +1
Quick Apply

We are building the real-world J.Senior Engineers excited about bridging the gap between materials/chemistry, data science, and computer science to help us develop a software framework for designin... Show more

Principal, Work Methods & Procedures Specialist

PG&E CorporationVacaville, California, US
Full-time

Requisition ID # 172160 Job Category: Maintenance / Construction / Operations Job Level: Manager/Principal Business Unit: Energy Delivery Work Type: Hybrid Job Location: Oakland; Antioch; Concord;... Show more

 • Promoted

Work from Home - Online Product Support (Entry Level)

GLOCPAFairfield, California
$15.00 hourly
Remote
Part-time +1

Product Testers are wanted to work from home nationwide in the US to fulfill upcoming contracts with national and international companies.We guarantee 15-25 hours per week with an hourly pay of bet... Show more

 • Promoted

Advanced Electronics / Computer Field Technician

US NavyMadison, 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

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

Customs and Border Protection Officer (CBPO) - Entry Level New Hire Sign-On and Retention Incentives

U.S. Customs and Border ProtectionMonument Hills, CA, US
Full-time

Customs and Border Protection Officer (CBPO).Customs and Border Protection (CBP) offers those interested in a career in law enforcement anexceptional opportunity to work with an elite team of highl... Show more

 • Promoted

Automotive Technician ASE Master Certified 2nd Shift 10k Sign On Bonus

CarmaxMadison, California, US
Full-time

Fairfield - 2955 Auto Mall Pkwy, Fairfield, California, 94533 CarMax, the way your career should be! Position Overview As a Mechanical Associate V, you'll play a critical role in ensuring every v... Show more

 • Promoted • New!

Software Engineer

ML OUTSOURCING SERVICES PRIVATE LIMITEDConcord, CA, United States
Full-time

SME - Recruitment at Mindlance | Building scalable service delivery model.Location: Concord, CA (Onsite/Hybrid – as required).Duration: 6 Months W2 contract.This range is provided by ML OUTSOURCING... Show more

 • Promoted • New!

Get Paid to Test Products at Home – Flexible Hours, Weekly Pay

OCPAMadison, California, us
$15.00 hourly
Part-time +1

Product Testers are wanted to work from home nationwide in the US to fulfill upcoming contracts with national and international companies.We guarantee 15-25 hours per week with an hourly pay of bet... Show more

 • Promoted

Electrical System Engineer with HVDC and HVAC

Avance ConsultingPleasant Hill, CA, United States
Full-time

Must Have Technical/Functional Skills:.Engineering experience and domain knowledge in EHV/ HV AC substations (AIS and GIS) systems and arrangement.Hands on Experience with Substation Primary design... Show more

 • Promoted • New!

Work At Home Online Entry Level - Remote Focus Group Panelist

Apex Focus Group LLCSuisun City, California, United States
Remote
Part-time

We're currently looking for individuals across the country to take part in remote paid research, including remote focus groups, product trials, and consumer studies.Earn up to $750 a week in your f... Show more

 • Promoted

Automotive Technician ASE Master Certified 2nd Shift 10k Sign On Bonus

CarMaxWinters, California, US
Full-time

Fairfield - 2955 Auto Mall Pkwy, Fairfield, California, 94533.CarMax, the way your career should be! .While professional experience and qualifications are key for this role, make sure to check you ... Show more

 • Promoted • New!

Remote Mechanical Engineer

Micro1Fairfield, California, US
Remote
Full-time

Real-world expertise is turned into training data, evaluations, and feedback loops that improve how models perform.AI labs and enterprises use micro1 to train models and build reliable AI agents th... Show more

 • Promoted

Work from Home – Product Feedback Support - $25-$45 per hour

GL Sierra Brooks, California
$25.00–$45.00 hourly
Remote
Full-time

We’re looking for Customer Support Product Testers across the US to work from home and help top brands improve their products before they hit the market. Show more

 • Promoted

Software Architect – Wind River Orchestration and Automation Platform

Wind RiverWalnut Creek, CA, United States
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