Associate CQV Engineer

Position Summary

The Associate 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:

• Work with other Instrument Support Engineers, and the Automation and laboratory teams to respond to instrument failures and ensure proper instrument function.
• Diagnose and troubleshoot any system concerns to minimize downtime.
• Install new laboratory equipment (e.g., liquid handlers, sequencers, plate sealers, etc.).
• Coordinate and/or perform instrument installations and qualifications per equipment protocols.
• Work with Quality Assurance to determine qualification (IQ/OQ/PQ), calibration and preventive maintenance requirements for new incoming instruments, as needed, to comply with regulations.
• Maintain program for preventative maintenance (PM), routine maintenance, and calibration of all laboratory equipment.
• Perform troubleshooting activities and provide Level 1 service; coordinate with Level II’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 years of industry-related experience.
• Experience supporting lab equipment or similar 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
• Adaptability in a frequently-changing environment
• Normally receives general instructions on routine work, detailed instructions on new projects or assignments
• Maintain a high level of professionalism and responsibility
• Must have strong communication, interpersonal and organizational skills
• Word processing and data management (MS Word, Excel, PowerPoint, etc.)

Preferred skills:

• Familiar with DNA Isolation and Purification, PCR, Cell Culture, Sequencing, etc.
• Experience operating automation or sequencing instrumentation.