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- Systems Upgrades
- Contractor Tasks and Responsibilities:
- Lab equipment is currently running on Windows 7 which is no longer supported. Consultant will be responsible for the qualification activities for the lab instruments for the new operating system and the new software upgrade.
- Skill, Experience Level, & "other" Background Requirements:
- Lab Instruments being qualified are.
- FTIR's
- Particle counters and DNA sequencers
- Develop and manage GxP system lifecycle documentation, including Validation Plans, User Requirements Specifications, Configuration Specifications, Testing Protocols (IQ/OQ/PQ), User Acceptance testing, Traceability Matrix, System, Validation Reports, SOPs, Change Control Documentation, and Risk assessment reports.
- Interface with internal stakeholders to lead project deliverables to completion.
- Conduct system compliance risk assessment as needed.
- Perform Data Integrity assessments, as needed.
- Ensure the data flow for each instrument family meets regulatory requirements
- Bachelor's degree in scientific or engineering discipline
- 5+ years' experience in Good Manufacturing Practice (GMP) / QA within FDA regulated environments.
- Experience in Instrument qualification/validation is a must.
- Experience with major change controls like upgrading operating systems is a Plus.
- Experience with some or all of the following instruments in the past - DNA Sequencers, Particle Counters, etc.
- Experience in developing full validation documentation and testing protocols (IQ/OQ/PQ/UAT) within the various SDLC phases.
- Excellent Technical Writing and Communication skills
Lab Instrument Qualification Engineer - Wilmington, United States - Katalyst Healthcares and Life Sciences
