Job Title: Laboratory Equipment & Validation Specialist
Position Overview
We are seeking an experienced Laboratory Equipment & Validation Specialist to oversee the planning, execution, and documentation for the qualification, calibration, and routine maintenance of laboratory instrumentation within a cGMP Quality Control (QC) facility.
This role manages all maintenance and calibration workflows through our Enterprise Asset Management / Computerized Maintenance Management System (CMMS). Additionally, the ideal candidate will author, own, and approve Validation Lifecycle documentation for computer-related lab systems-including conducting Data Integrity testing and serving as a business administrator for laboratory IT infrastructure.
Key Responsibilities
- Routine Maintenance & Calibration: Plan, execute, and review routine calibration, requalification, and maintenance schedules for laboratory equipment via the CMMS. Review and archive all QC equipment documentation.
- Qualification & Validation: Lead the end-to-end qualification of new laboratory equipment in a cGMP environment. Draft, execute, and summarize validation protocols and associated reports.
- Lifecycle Management: Conduct periodic reviews of instrument validation states as part of continuous validation lifecycle management.
- Deviations & Investigations: Alert QC Leadership regarding equipment failures or out-of-spec calibrations; lead formal impact assessments and root-cause investigations.
- Vendor & Service Management: Schedule and coordinate equipment repairs, preventive maintenance, and vendor service visits to minimize lab downtime and operational disruption.
- Cross-Functional Expertise: Serve as a Subject Matter Expert (SME) on instrument validation regulations and procedures within technical project teams.
- Change Control & Data Integrity: Project manage change controls, ensure compliance with key performance metrics, and act as a key contributor to Data Integrity Assessments for laboratory systems.
- System Administration: Support the onboarding of new assets and components into the CMMS system, alongside other duties assigned by management.
Qualifications & Experience
- Education: Bachelor's degree in a Scientific or Technical discipline required.
- Experience: Minimum of 3 years working in a cGMP laboratory environment, with direct experience in analytical instrument validation and data integrity assessments.
- Technical Knowledge: Deep understanding of biopharmaceutical testing methodologies, analytical instrumentation, and relevant regulatory requirements for cGMP laboratory equipment validation and electronic record integrity (e.g., 21 CFR Part 11 / Annex 11).
- Track Record: Proven ability to manage an equipment qualification or maintenance program is strongly preferred.
