Commission, Qualification and Validation (CQV) Engineer II

• BS/BA in a biological science/biomedical engineering, similar field of study, or comparable industry experience

• 1-3 years industry related experience

• Experience supporting laboratory equipment required

• Provides Level 2 support for all laboratory equipment,  troubleshooting hardware and software with some support from Level 3, Automation, and vendor.

• Work with other Instrument Service Engineers, and the Automation and laboratory teams to respond to instrument failures and ensure proper instrument function, providing  Level 2 support for all laboratory equipment.

• Diagnose and troubleshoot any system concerns to minimize downtime, with the technical skills of a Level II, troubleshooting hardware and software with some support from Level 3, Automation, and vendor.

• Install new laboratory equipment (e.g., liquid handlers, sequencers, plate sealers, etc.) to support lab capacity or new projects

• Qualify all instruments are appropriately qualified, creating and updating equipment protocols as needed.

• Support of new instrumentation and project deliverables.

• Develop and execute procedures for the cleaning and maintenance of  laboratory instrumentation

• Develop and revise instrument qualification protocols in accordance with design requirements, operational needs, and applicable standards

• Coordinate new automation equipment installations by reaching out to necessary groups to ensure necessary MEPs are in place

• Work with process engineering and QA teams to facilitate introduction of new equipment types into clinical laboratory

• Work with different departments to determine qualification (IQ/OQ/PQ), calibration and preventive maintenance requirements for new incoming instruments, as needed, to comply with regulations and meet process requirements.

• Maintain program for preventative maintenance (PM), routine maintenance, and calibration of all laboratory equipment.

• Perform troubleshooting activities and provide Level 2 service; coordinate with Level 3’s and vendors to address escalated service concerns.

• Recommend and implement changes to ensure ongoing high-quality performance of laboratory equipment.

• Perform all service activities in compliance with all relevant safety and regulatory bodies (e.g., OSHA, CAP, CLIA, etc.).

• Maintain and continuously develop knowledge and expertise related to the service of clinical laboratory equipment.

• Track all service activities utilizing system(s) developed in accordance with service procedures and laboratory policies.

• Ensure all service documentation is complete, timely, and accurate following Good Documentation Practices (GDP).

• Excellent verbal and written English communication skills.

• Adaptable, open to change, and the ability to work in ambiguous situations while responding to new information and unexpected circumstances.

• Strong interpersonal and teamwork skills; ability to easily convey concepts and priorities, as well as an ability to solicit feedback and inputs.

• Support and comply with the company’s Quality Management System policies and procedures.

• Coordinate duties with Equipment Technician

• Perform other tasks as specified by the supervisor/manager

• This role works with PHI on a regular basis both in paper and electronic form and have access to various technologies to access PHI (paper and electronic) in order to perform the job

• Employee must complete training relating to HIPAA/PHI

privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.

• Must maintain a current status on Natera training requirements.