Job Description
We are seeking an experienced professional to manage the qualification, calibration, and routine maintenance of laboratory systems in a cGMP Quality Control environment.
This role involves ensuring compliance with regulatory standards, maintaining equipment, and supporting data integrity and validation.
The ideal candidate will have 3+ years experience in a cGMP lab including experience in laboratory systems lifecycle management, a deep understanding of validation and calibration, and a strong focus on operational efficiency and regulatory compliance.
Key Responsibilities:
* Calibration & Maintenance: Plan and execute routine calibration, requalification, and maintenance of lab equipment in CMMS. Review and file QC documentation.
* Equipment Qualification: Lead qualification of new laboratory equipment, write validation protocols, and summarize reports.
* Validation Reviews: Conduct periodic reviews of equipment validation throughout its lifecycle.
* Issue Management: Alert management to equipment failures, perform impact assessments, and lead investigations.
* Coordination: Schedule repairs and maintenance with vendors while minimizing equipment downtime.
* Expert Guidance: Act as a subject matter expert on validation regulations and contribute to change control processes.
* Data Integrity: Support Data Integrity Assessments and ensure compliance with relevant regulations.
Qualifications:
* Education: Bachelor's degree in a Science-related field.
* Experience: 3+ years in a cGMP laboratory environment with experience in instrument validation and data integrity.
* Technical Knowledge: Strong understanding of laboratory methodologies, instrumentation, and cGMP regulations.
* Project Management: Experience managing equipment qualification/maintenance programs and projects in CMMS.