Lab Instrument Software Validation SME
Share
Job Location:
Cincinnati, OH - USA
Monthly Salary:
Not Disclosed
Posted on:
2 hours ago
Vacancies:
1 Vacancy
Job Summary
Job title: Lab Instrument Software Validation SME
Location: Cincinnati OH (Onsite)
Type: Contract
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.
