Overview In this role you qualify analytical and microbiological instrumentation within QC, coordinating qualification, calibration and maintenance to ensure equipment meets intended use. You will support QC Microbiology and QC Chemistry by managing equipment histories and serving as the point of contact for instrumentation issues. The job involves vendor coordination, training, and planning validation activities to sustain compliant lab operations. This position offers hands-on impact in a regulated environment with opportunities to shape qualification processes and equipment lifecycle. A clear hook is contributing to reliable, compliant lab testing at scale.
Responsibilities- Coordinate qualification, calibration and maintenance of laboratory equipment and related systems
- Coordinate purchase, commissioning and introduction to service of new equipment
- Establish and maintain Equipment History Files (EHF) for QC laboratory equipment
- Act as contact point for instrumentation issues and provide training and troubleshooting support
- Coordinate services by vendors ensuring site requirements are met
- Schedule/plan/execute validation activities and preventive maintenance of laboratory equipment
Key requirements- Knowledge of USP 1058 and GAMP methodology
- Knowledge of 21CFR Parts 11, 210, 211, 600 and 610
- Experience with Empower and LIMS
- Hands-on experience performing laboratory equipment qualification
- Proficient in Outlook, Microsoft Word and Excel and lab data management systems
- Ability to gown and enter laboratory
- May require off shift work to support activities
- Demonstrated scientific technical writing ability
- Strong communication and training skills
- Problem solving and troubleshooting mindset
- USP 1058 and GAMP knowledge
- 21CFR Parts 11, 210, 211, 600, 610 knowledge
- Empower and LIMS experience
