97 applicants

Company

Original Job Post

ProPharma · 4 days ago

DI CSV Validation Engineer

United States

Full-time

Remote

Mid, Senior Level

5+ years exp

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Responsibilities

Participate on teams in delivering CSV projects.

Author functional requirements specifications, system Risk Assessments, Validation Plans, and Reports.

Execute validation testing protocols and document results.

Prepare project status reports for clients and management.

Extensive travel may be required at times.

Other duties as assigned.

Qualification

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Computer system validationSoftware testingFDA regulationsIndustry best practicesValidation experienceSystem delivery modelsExperience in specific industriesCommunicationTeamwork

Required

Experience in the validation at least two of these computer system categories: automation control, laboratory systems, quality management systems, ERPs, clinical trial and pharmacovigilance applications.

Experience in validation of multiple system delivery models including SaaS, PaaS, IaaS, and On Prem.

Working knowledge of software testing techniques and test case development best practices.

Working knowledge of FDA 21 CFR 11, EU Annex 11 and supporting guidance documents.

Working knowledge of industry best practices such as GAMP5, ANSI standards (S-95, S-88), and ASTM (E2500).

Able to work effectively with local and virtual team members and other professionals, such as QA specialists, software developers, and system users.

Effective written and oral communication skills; ability to write, type, express or exchange ideas of a technical nature by means of the spoken word; convey information/instructions accurately; receive detailed information through oral or written forms and to translate those instructions into physical execution of tasks.

AS or B.S./B.A. in Software Engineering, Computer Science, Information Technology, or a related field.

Minimum 5 years of experience in the field of Computer System Validation.

Minimum 2 years of experience in Pharmaceutical, Medical Device, Clinical Research, or Healthcare Industries.

Company

ProPharma

Glassdoor

3.1

ProPharma is the premier Research Consulting Organization (RCO), delivering fully customizable consulting solutions to empower biotech, med device, and pharmaceutical organizations of all sizes to advance scientific breakthroughs confidently and introduce new therapies.

Founded in 2001

Overland Park, Kansas, USA

5,001-10,000 employees

http://www.propharmagroup.com/

H1B Sponsorship

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Trends of Total Sponsorships

2023 (4)

2022 (4)