Validation/Calibration Technician II
Hiring Company: Prometheus Labs
Location: San Diego, CA
Job Type: Non-Exempt
Perform all equipment record processing functions and perform and appropriately document routine calibration and qualification of a variety of analytical, manufacturing and facility equipment.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
• Adhere to Good Manufacturing Practices (GMPs), including adherence to all company SOPs and documentation standards
• Maintain clear, concise, and compliant records of all work performed for the purpose of documenting the control of all equipment and utilities
• Label new equipment with Equipment ID Numbers and follow up with all involved parties to complete New Equipment Forms
• Coordinate the monthly calibration schedule by running events due lists, contacting the responsible parties, and scheduling the work with the equipment owners
• Make data entries into the RAM (Regulatory Asset Manager) equipment database
• File equipment-related documentation into the Equipment Master Files
• Issue qualification protocols for execution, and compile/package/route executed qualification documents
• Perform routine calibrations and requalifications on basic and complex equipment types
• Perform both scheduled and unscheduled maintenance on laboratory, facility, and manufacturing equipment, when required
• Review calibration documents for accuracy and completeness
• Maintain all metrology standards in working condition and ensure that they are used within their calibration intervals
• Assist in gathering and shipping equipment that requires off-site calibration
• Write calibration procedures, worksheets, and specifications
• Monitor timely completion of OOT (Out-of-Tolerance) reports and ECR (Equipment Change Request) forms, and follow up with appropriate parties to communicate upcoming due dates
• Facilitate equipment-related process improvements, such as implementation of equipment logbooks
• Move and install equipment, when required
• Other duties as assigned
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
Generally requires a high school degree, a Bachelors of Science degree in a scientific field is preferred, with 2 -4 years of related experience. Experience in a manufacturing or laboratory environment, as well as knowledge about laboratory controls and safety is required. Experience working in a FDA GXP and/or QSR regulated environment is strongly preferred. Computer skills competency including Excel, Word and PowerPoint programs is required. Experience with operating, calibrating, qualifying, and/or maintaining laboratory or manufacturing equipment is required.