The specialist ensures full compliance with internal procedures and industry best practices such as 21 CFR Part 11 and GAMP5 for laboratory systems
Job Summary
The specialist ensures full compliance with internal procedures and industry best practices such as 21 CFR Part 11 and GAMP5 for laboratory systems.
Responsibilities include leading multiple validation projects simultaneously while managing the full lifecycle of laboratory equipment and software.
The role offers a competitive salary range and comprehensive wellness benefits to support employee health and professional growth.
Matching Summary
The specialist ensures full compliance with internal procedures and industry best practices such as 21 CFR Part 11 and GAMP5 for laboratory systems.
Salary
Base: $93,200.00 - $155,300.00 annualized; Bonus/Equity: Incentive plans and bonuses may be offered; Benefits: Integrated wellness programs and health coverage available
Skills & Requirements
Must-have
21 CFR Part 11 compliance
GAMP5 best practices
IQ/OQ/PQ protocol execution
Regulated environment experience
Complex Excel spreadsheet validation
Nice-to-have
Mentoring junior specialists
Environmental monitoring system administration
Cross-functional stakeholder collaboration
Hardware and software troubleshooting
Key Requirements
Bachelor's degree in Computer Science, Software Engineering, or Sciences
Minimum 5 years of validation experience in regulated environments
Functional knowledge of English written and spoken