Certified Laboratory Equipment Specialist
3 days ago
Ensure Laboratory Systems Accuracy
The Quality Control (QC) laboratory equipment specialist plays a crucial role in guaranteeing the precise and efficient operation of laboratory systems within a cGMP regulated environment.
The successful candidate will be responsible for planning, executing, and documenting the qualification, calibration, and routine maintenance of laboratory equipment. This includes ensuring compliance with Computerized Maintenance Management System (CMMS) Maximo schedules and regulatory requirements.
Main Responsibilities:- Equipment Calibration and Maintenance: Plan, conduct, and document routine calibration, requalification, and maintenance of laboratory equipment to ensure ongoing compliance with CMMS Maximo schedules and regulatory requirements.
- Instrument Validation: Qualify new laboratory equipment in a cGMP regulated environment by writing equipment validation protocols and associated summary reports.
- Ongoing Compliance: Conduct periodic reviews of instrument validation as part of the validation life cycle to ensure ongoing compliance.
- Alerting and Reporting: Alert Quality Control Management in the event of equipment failing to meet calibration or qualification requirements and conduct impact assessments/investigations as required.
- Scheduling and Coordination: Schedule and coordinate equipment repairs and maintenance with vendors/contractors to minimize downtime and disruption to laboratory activities.
- Technical Project Teams: Participate in technical project teams to provide subject matter expertise on instrument validation regulations and procedures.
- Change Control: Own and project manage change controls and adherence to Change Control metrics where applicable.
- Data Integrity Assessments: Support and manage the addition of project components to CMMA Maximo and act as a key contributor and sponsor to Data Integrity Assessments for Lab systems.
- Bachelor's Degree: A Bachelor's degree in a Science-related field is required.
- Laboratory Experience: Minimum of 3 years of laboratory experience in a cGMP laboratory environment including exposure to analytical instrument validation and data integrity assessments.
- Methodology Knowledge: Detailed knowledge of methodology, instrumentation, and analytical techniques used for biopharmaceutical testing.
- Regulatory Understanding: Understanding of current regulatory requirements for cGMP laboratory equipment validation and electronic record integrity.
- Equipment Management: Demonstrated success in managing an equipment qualification or maintenance program is advantageous.
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