Commission, Qualification and Validation (CQV) Engineer II

POSITION SUMMARY:

The CQV Engineer is responsible for the service and support of laboratory equipment and instrumentation utilized in the Operations laboratory. The scope of support includes installation, calibration, maintenance, and repair of both simple (e.g., plate sealers) and complex (e.g., liquid handling robotics) instrumentation in the laboratory. The Instrument Service Engineer will be the primary point of contact for production lab personnel when equipment and instruments are not operating or not meeting operational specifications. 

PRIMARY RESPONSIBILITIES:

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.

QUALIFICATIONS:

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

KNOWLEDGE, SKILLS, AND ABILITIES:

Ability to analyze and problem solve issues

Excellent attention to detail and accuracy

Ability to promote a positive team environment

Candidate must be a self-starter who can independently drive projects and day-to-day work tasks to completion according to schedule

Adaptability in a frequently-changing environment

Maintain a high level of professionalism and responsibility

Good technical writing and communication skills

Must have strong interpersonal and organizational skills

Computer skills (MS Word, Excel, PowerPoint, etc.)

Familiar with DNA Isolation and Purification, PCR, Cell Culture, Sequencing, etc.

Experience with automation and sequencing instrumentation