Senior Laboratory Systems Engineer #4071

Responsibilities:

• Diagnose and resolve issues with laboratory systems and equipment integrated into distributed environments, ensuring minimal downtime and optimal performance. 
• Lead implementation of programs and workflow systems to support complex automated processes in a clinically regulated environment
• Collaborate with cross-functional teams to address connectivity, data synchronization, and system compatibility challenges between distributed devices and platforms. 
• Reduce and improve unplanned maintenance wherever feasible. Prolong the economic life of assets at the lowest practical cost.
• Develop automated engineering solutions to resolve/mitigate repetitive failures that adversely affect plant availability, performance, capacity, quality, cost, or regulatory compliance.
• Develop & update comprehensive documentation such as qualification protocols, standard operating procedures (SOP), Work Instructions (WI), How-To-Articles, and Troubleshooting Guides
• Facilitate knowledge-sharing initiatives to improve team proficiency and reduce dependency on individual expertise
• Execute Equipment Lifecycle Management processes and procedures by supporting and maintaining equipment records for traceability purposes in compliance with CLIA/CAP, FDA 21 CFR Part 820, and ISO 13485 / 15189 requirements, and the GRAIL QMS (Quality Management System)
• Support the investigations in NCRs, CAPAs, and associated quality and technical investigations

Preferred Qualifications:

• 5+ years of related experience with a BS/BA or higher degree in Engineering or equivalent work experience.
• 5+ years experience troubleshooting and maintaining laboratory equipment in distributed or networked environments 
• 5+ years experience writing scripts for equipment automation tools, log analysis, and/or system monitoring (PowerShell, Python, etc…) in windows based environments. Familiarity utilizing scripting for API interactions, data parsing, and troubleshooting distributed systems. 
• 5+ years experience with Laboratory Information Management Systems (LIMS), Manufacturing Management Systems (MES), Customer Relationship Management (CRM) software
• 3+ years experience with real-time, process optimization automated laboratory scheduling software 
• 3+ years experience with data analysis techniques including statistical process control, OEE, reliability modeling and prediction, RCA techniques, and/or six sigma methodology 
• 3+ years experience using an asset computerized maintenance management system (CMMS)
• 3+ years experience maintaining low volume automated liquid handling systems (e.g. MultiFlo/Bravo, STAR/STARlet, Echo, Lynx, Lunatic, high throughput NGS sequencers)
• 3+ years experience with remote equipment access and control tools to support troubleshooting across geographically dispersed environments
• 3+ years experience project management 
• 3+ years experience with an Open Source code repository and collaborative software development platform (Gitlab)
• 3+ years experience with LIMS, open source code repository, and automated laboratory scheduling applications
• Ability to work independently and as part of a team

Physical Demands & Working Environment

• Regularly required to stand, sit, walk, climb stairs/ladders, kneel, crouch, and wear safety gear.
• Hours and days may vary depending on operational needs.
• Working with dry ice may be necessary.
• Standing or sitting for long periods of time may be necessary.
• May be exposed to hazardous materials, blood specimens and instruments with moving parts, heating or freezing elements, and high speed centrifugation.
• Must occasionally lift and / or move up to 10 pounds.
• Must occasionally lift and/or move up to 25 pounds.
• Must occasionally lift and/or move up to 50 pounds.
• Travel may be required, up to 10% of the time.