Job Opportunity
The Equipment Validation Specialist role involves overseeing the qualification, calibration, and routine maintenance of laboratory systems in a regulated environment.
Responsibilities:
* Develop and execute schedules for equipment calibration, requalification, and maintenance to ensure compliance with regulatory requirements.
* Conduct qualifications of new laboratory equipment in a cGMP setting, including writing protocols and summary reports.
* Review and maintain instrument validation records as part of the validation life cycle.
* Alert management to equipment failures not meeting calibration or qualification standards and conduct impact assessments when necessary.
* Schedule and coordinate equipment repairs and maintenance with vendors while minimizing downtime and disruptions.
* Participate in technical project teams providing expertise on instrument validation regulations and procedures.
* Manage change controls and metrics adherence where applicable.
* Support CMMS Maximo by adding project components.
* Assist with Data Integrity Assessments for Lab systems.
Requirements:
* Bachelor's degree in a Science-related field is required.
* At least 3 years of laboratory experience in a cGMP environment, including analytical instrument validation and data integrity assessments.
* Detailed knowledge of biopharmaceutical testing methodologies, instrumentation, and techniques.
* Understanding of current regulatory requirements for laboratory equipment validation and electronic record integrity.
* Previous success in managing an equipment qualification or maintenance program is advantageous.