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Lab Instrument Software Validation SME - Cincinnati, OH - Onsite - ()

Cincinnati, OH, US • Posted 6 days ago • Updated 6 days ago

Contract Independent

Contract Corp To Corp

Contract W2

No Travel Required

On-site

Depends on Experience

Fitment

Dice Job Match Score™

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Job Details

Skills

GxP
LIMS
CSV
Computer System Validation
lab instruments

Summary

Lab Instrument Software Validation SME

Onsite working.

Client Location: 2110 East Galbraith Road, Cincinnati, OH 45237

Duration is 6 months

Project Overview:

Document and validate software installed on ~200 lab instruments globally in accordance with EMA guidelines
Transition ongoing software management to PPD IT software management SOPs
Document current-state software configurations and requirements

Scope of Work Includes:

Gathering and documenting requirements
Authoring validation test cases
Developing software specifications
Creating infrastructure and data flow diagrams
Performing risk assessments

Staffing Request:

4–6 resources to augment the current team
Target start: June
Estimated duration: ~6 months
Resources should be located near our US lab operations or our Brussels, Belgium lab to enable close collaboration

Required Capabilities:

Strong technical writing expertise
Effective stakeholder communication
High attention to detail in regulated environments

We are requesting an updated proposal that outlines:

Estimated timeline and resourcing approach
Cost structure (including any assumptions)
Relevant experience with similar validation efforts

Our goal is to review proposals and align on a path forward within the next two weeks.

Please let me know if you need any additional information to support your proposal. I appreciate your time and look forward to your response.

Thanks & Regards,

Sriram Chaganti

Talent Acqusition Specialist | Vivid Soft Global Inc.

Email:

eye

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 10204540
Position Id: 85126-2308-
Posted 6 days ago

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