CQV Engineer

Description

The role supports laboratory equipment and instruments used in the operations lab, from simple devices such as plate sealers to complex liquid handling robotics. This covers installation, calibration, maintenance and repair. The engineer is the main contact for production lab staff when equipment is down or falls outside operating specifications.

The company is a global leader in cell-free DNA (cfDNA) testing, focused on oncology, women's health and organ health. Its goal is to make personalized genetic testing and diagnostics a standard part of care, enabling earlier and more targeted treatment. The team includes statisticians, geneticists, doctors, laboratory scientists, business professionals and software engineers.

Responsibilities

• Provide Level 2 support for all laboratory equipment, troubleshooting hardware and software, with help from Level 3, automation and vendors when needed.
• Diagnose and fix system problems quickly to limit downtime.
• Respond to instrument failures with other Instrument Service Engineers, the automation team and the lab team, so instruments run correctly.
• Install new laboratory equipment, such as liquid handlers, sequencers and plate sealers, to add capacity or support new projects.
• Qualify instruments and create and update equipment protocols as needed.
• Write and revise instrument qualification protocols based on design requirements, operational needs and applicable standards.
• Develop and carry out cleaning and maintenance procedures for lab instruments.
• Maintain the preventive maintenance, routine maintenance and calibration program for all lab equipment.
• Work with other departments to set IQ/OQ/PQ, calibration and preventive maintenance requirements for new instruments, so they meet regulations and process needs.
• Confirm that the required utilities (MEPs) are in place by contacting the right groups before new automation equipment is installed.
• Work with process engineering and QA to bring new equipment types into the clinical lab.
• Coordinate escalated service issues with Level 3 staff and vendors.
• Recommend and make changes that keep laboratory equipment performing at a high quality.
• Carry out all service work in line with relevant safety and regulatory requirements, such as OSHA, CAP and CLIA.
• Keep your knowledge of clinical laboratory equipment service current and keep building it.
• Log all service activity in the designated system, following service procedures and lab policies.
• Keep service documentation complete, timely and accurate under Good Documentation Practices (GDP).
• Support and follow the company's Quality Management System policies and procedures.
• Coordinate your work with the Equipment Technician.
• Complete other tasks your supervisor or manager assigns.
• Handle protected health information (PHI) in paper and electronic form, using the systems needed for the job.
• Complete HIPAA/PHI privacy, general policies and procedures compliance, and security training within the first 30 days, and keep your the company training requirements current.

Requirements

• A BS or BA in a biological science, biomedical engineering or a similar field, or equivalent industry experience.
• 1 to 3 years of industry experience.
• Experience supporting laboratory equipment.
• Experience with automation and sequencing instruments.
• Familiarity with DNA isolation and purification, PCR, cell culture, sequencing and similar techniques.
• Strong analytical and problem-solving skills.
• Excellent attention to detail and accuracy.
• Excellent written and verbal English communication, including clear technical writing.
• Strong interpersonal, teamwork and organizational skills, with the ability to explain concepts and priorities and to ask for and act on feedback.
• Proficiency with computer tools such as MS Word, Excel and PowerPoint.
• Self-motivated, able to drive projects and daily tasks to completion on schedule.
• Comfortable adapting to a frequently changing environment, including ambiguous situations and unexpected changes.
• High standards of professionalism and responsibility.
• Helps build a positive team environment.

Conditions

Equal opportunity employer that welcomes candidates of all backgrounds, experiences, abilities and perspectives.

Candidates based in California should review the company's notice on data collection for California residents.

Benefits

• Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents.
• Free testing and fertility care benefits for employees and their immediate families.
• Pregnancy and baby bonding leave, 401(k), commuter benefits and more.
• Employee referral program.