Equipment Engineer 1 # 4649

The Equipment Engineer I will be responsible for supporting the development and documentation of return-to-service procedures following maintenance, repairs, or major modifications to advanced laboratory equipment, all in alignment with applicable regulatory requirements.The supported equipment spans a broad range, including next-generation sequencing (NGS) platforms and automated liquid handling systems. The engineer will work closely with Engineering Operations, Process Engineering, Automation Engineering and Quality Assurance. Success in this position requires strong interpersonal skills, effective technical writing, and exceptional troubleshooting abilities.

This position is onsite full-time, with 5 days per week at our Durham, NC facility. Additionally, the role requires participation in a rotating schedule for weekend and holiday coverage (when applicable), as part of ensuring continuous support for critical laboratory operations.

Responsibilities:

• Perform and document  troubleshooting, recovery, debugging, and repairs on laboratory systems and equipment. 

• Create and update: procedures, work instructions, guidelines, and testing documents such as installation / operational / verifications, standard operating procedures (SOP)

• Support root cause investigations that drive for resolutions to completion.

• Execute Equipment Lifecycle Management processes and procedures by supporting and maintaining equipment records for traceability purposes in compliance with CLIA/CAP and ISO 13485 requirements.

• Collaborate with validation engineers to draft, review and execute equipment qualification  protocols.

• Recommend and implement changes to ensure ongoing high-quality and efficient engineering operations procedures as part of the continuous improvement process.

• Support the planning and execution of qualification activities ensuring compliance with established procedures and guidelines. 

• Participate and adhere to GRAIL’s policies and guidelines

• Work closely with Compliance, Engineering, Quality and Regulatory to implement and follow the required policies and procedures for the lifecycle of equipments

• Partner cross-functionally to enable effective technology transfer and continuous workflow improvements.

Required Qualifications:

• Bachelor’s degree or equivalent in Engineering, Physics, Chemistry, or similar Life Sciences discipline. 

• 1+ years generating technical documentation within a regulated environment

• 1+ years experience completing work in accordance with stated deadlines 

• 1+ years experience contributing to cross-functional team initiatives

• 1+ years technical troubleshooting and root cause analysis experience

• Good to excellent communication skills to work independently and provide internal customer support.

• Good to excellent time management skills to support a fast paced working environment.

• Basic to good knowledge of laboratory equipment and systems.

• Basic to good knowledge creating and interpreting process and material flow diagrams

• Ability to take initiative and independently drive projects to completion with detailed and efficient execution and reporting

Preferred Qualifications:

• Bachelor’s degree or equivalent in Engineering preferred.

• 1+ years experience with asset management softwares

• 1+ years experience using Laboratory Information Management Systems (LIMS)

• 1+ years experience maintaining low volume automated liquid handling systems (e.g. MultiFlo/Bravo, STAR/STARlet, Echo, Lynx, high throughput NGS sequencers)

• 1+ years experience writing and implementing test protocols and procedures

• 1+ years experience using Green Button Go

Physical Demands & Qualifications

• Regularly required to stand, sit, walk, climb stairs/ladders, kneel, crouch, and wear safety gear.

• Occasionally work with dry ice or materials stored at very low temperatures.

• Must be able to stand or sit for long periods of time. 

• May be exposed to hazardous materials, blood specimens and instruments with moving parts, heating or freezing elements, and high speed centrifugation.

• Must regularly lift and / or move up to 10 pounds.

• Must frequently lift and/or move up to 25 pounds.

• Must occasionally lift and/or move up to 50 pounds.