San Francisco Metro Area, CA
- The Equipment Technician will be responsible for integration, implementation, service, maintenance and movement of laboratory equipment. This will include automation and instrumentation in support of a Clinical, Research and various GxP Laboratories. This includes installation, configuration, repair of equipment, validation and verification of the equipment in accordance with CLIA, cGMP and/or GLP guidelines. Responsible for preparing and executing documentation for a licensed Clinical Laboratory Scientist review while following the manufacturers and the Equipment Quality system work instructions. The Equipment Technician will trouble-shoot problems with equipment and conduct or coordinate required repairs and complex maintenance tasks. The Equipment Technician will assist, plan and execute logistics set by Equipment Engineering Staff for the successful move of laboratory equipment for multiple business units
- Perform trouble-shooting and repairs on all automated laboratory equipment.
- Serve as point of contact for equipment manufacturers and Service Representatives
- Document and perform equipment Calibration, Preventive Maintenance, Repairs, IOPQ, validation and other equipment lifecycle processes to support a regulated lab
- Create and execute validation protocols for all new and modified equipment
- Ensure that all work performed by external contractors is completed in compliance with policies Author technical documents including Standard Operating Procedures (SOPs), Validation Protocols and Reports.
- Knowledge troubleshooting or manufacturing NGS Sequencers is a plus.
- Strong project management skills, organizational skills, and written and verbal communication skills are required.
- Flexibility and self-initiative required to support several simultaneous automation support.
- Preparing calibration documents, operating within a Laboratory Information management system
- Preparing, performing and documenting functional and validation testing, IQ/OQ/PQ.
- Biotech, pharmaceutical, Lab automation providers, or clinical-laboratory experience is highly desirable.
- 1 to 5 years of relevant experience supporting a GxP laboratory setting
- Technical, AA, AS, BS degree in Biomedical engineering or closely related field with Technical proficiency
- Experience in service and maintenance of equipment for the life sciences industry; including liquid handling systems such as Tecan, Hamilton, Beckman, Agilent is a plus.
- Technical CERT, AA/AS,BS