CQV Engineer

Description

The role supports laboratory equipment and instruments used in the Operations lab, covering installation, calibration, maintenance and repair, from simple devices such as plate sealers to complex liquid handling robotics.

You will be the main contact for production lab staff when equipment is down or not meeting operational specifications.

Responsibilities

• Provide Level 2 support for all lab equipment, troubleshooting hardware and software, with help from Level 3, Automation and vendors when needed.
• Work with other Instrument Service Engineers and the Automation and lab teams to respond to instrument failures and confirm instruments perform correctly.
• Diagnose and fix system problems quickly to reduce downtime, using Level II technical skills.
• Install new lab equipment such as liquid handlers, sequencers and plate sealers to add capacity or support new projects.
• Support new instrumentation and project deliverables.
• Qualify instruments and create and update equipment protocols as needed.
• Write and carry out procedures for cleaning and maintaining lab instruments.
• Write and revise instrument qualification protocols based on design requirements, operational needs and applicable standards.
• Contact the necessary groups to confirm that utilities and other prerequisites are in place before new automation equipment is installed.
• Work with process engineering and QA to bring new equipment types into the clinical lab.
• Work with different departments to set qualification (IQ/OQ/PQ), calibration and preventive maintenance requirements for new instruments, so they meet regulations and process needs.
• Maintain the preventive maintenance, routine maintenance and calibration program for all lab equipment.
• Handle troubleshooting and Level 2 service, and coordinate with Level 3 staff and vendors on escalated issues.
• Recommend and make changes that keep lab equipment performing at a high quality level.
• Carry out all service work in line with applicable safety and regulatory rules, such as OSHA, CAP and CLIA.
• Keep building your knowledge of clinical lab equipment service.
• Log all service activity in the tracking system, following service procedures and lab policies.
• Make sure service documentation is complete, timely and accurate under Good Documentation Practices (GDP).
• Support and follow the company's Quality Management System policies and procedures.
• Coordinate tasks with the Equipment Technician.
• Complete other tasks your supervisor or manager assigns.
• Work regularly with PHI in paper and electronic form, using the systems needed to access it for the job.
• Complete HIPAA/PHI privacy, General Policies and Procedures compliance, and security training within your first 30 days, sooner if possible.
• Keep your the company training requirements current.

Requirements

• A BS or BA in a biological science, biomedical engineering or similar field, or equivalent industry experience.
• 1-3 years of related industry experience.
• Experience supporting laboratory equipment is required.
• Strong analytical and problem-solving skills.
• Careful attention to detail and accuracy.
• Able to help build a positive team environment.
• Self-motivated, able to move projects and daily tasks to completion on schedule without close supervision.
• Comfortable adapting to a frequently changing environment.
• Professional and responsible in your conduct.
• Clear technical writing and communication.
• Strong interpersonal and organizational skills.
• Proficient with computer tools such as MS Word, Excel and PowerPoint.
• Familiar with DNA isolation and purification, PCR, cell culture, sequencing and similar techniques.
• Experience with automation and sequencing instruments.
• Excellent verbal and written English.

Conditions

The pay range is a good-faith estimate of base pay at hire; final pay depends on experience, qualifications and skills.

Base pay range: $88,300 - $110,350 USD.

The role is also eligible for compensation and benefits through the company's Total Rewards program.

Equal-opportunity employer.

Benefits

• Comprehensive medical, dental and vision coverage.
• 401(k) with company match.
• Generous paid time off and company holidays.
• Additional wellness and work-life benefits.
• Life and disability plans for eligible employees and dependents.
• Free testing and fertility care benefits for employees and immediate family.
• Pregnancy and baby bonding leave, commuter benefits and an employee referral program.