CSV Engineer jobs in United States
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Capgemini Engineering · 2 months ago

CSV Engineer

positionWinter Haven, FL
timeFull-time
remoteOnsite
seniorityMid Level

Capgemini Engineering is a global leader in engineering services, bringing together a diverse team to support innovative companies across various industries. They are seeking a skilled Computer System Validation (CSV) Consultant to ensure compliance with regulatory requirements and maintain the integrity of computerized systems in the Life Sciences sector.

ConsultingInformation ServicesInformation TechnologyInnovation ManagementMechanical Engineering
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H1B Sponsor Likelynote

Responsibilities

Experience in Computer System Validation (CSV) within the Life Sciences industry
Experience with MES and LIMS systems is a nice-to-have
In-depth knowledge of regulatory requirements such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines
Strong analytical and problem-solving skills, with the ability to conduct thorough risk assessments and impact analyses
Excellent documentation skills and attention to detail
Good command of English

Qualification

Computer System ValidationFDA 21 CFR Part 11EU Annex 11GAMP 5 guidelinesManufacturing Execution SystemsLaboratory Information Management SystemsAnalytical skillsEnglish proficiencyProblem-solving skillsDocumentation skillsAttention to detail

Required

Experience in Computer System Validation (CSV) within the Life Sciences industry
In-depth knowledge of regulatory requirements such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines
Strong analytical and problem-solving skills, with the ability to conduct thorough risk assessments and impact analyses
Excellent documentation skills and attention to detail
Good command of English

Preferred

Experience with MES and LIMS systems is a nice-to-have

Benefits

Health and life insurance
Referral program with bonuses for talent recommendations

Company

Capgemini Engineering

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Capgemini Engineering is a global innovation and engineering consulting firm.
dateFounded in 1982
location
Paris, Ile-de-France, FRA
people-size10001+ employees
web-link
https://www.capgemini.com/in-en/about-us/who-we-are/our-brands/capgemini-engineering/

H1B Sponsorship

Capgemini Engineering has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (1)
2021 (12)
2020 (24)

Funding

Current Stage
Public Company
Total Funding
$4M
2019-06-24Acquired
2006-09-19Post Ipo Equity· $4M
1990-01-05IPO

Leadership Team

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Joao Neiva
Automotive Mobility Experience Offer Leader
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Pascal Brier
Group EVP Strategy, Technology & Inovation
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Recent News

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Company data provided by crunchbase