Systems Engineer II - Strategy 1st/2nd/3rd Shift (RTP, NC) #3523

Responsibilities;

• Perform troubleshooting, recovery, debugging, and repairs on laboratory systems and equipment in a regulated environment
• 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 and improve embedded equipment software method management and virtual machine management processes. 
• Reduce and improve unplanned maintenance wherever feasible, assuring efficient and productive operation of equipment. Prolong the economic life of assets at the lowest practical cost.
• Support engineered solutions to mitigate repetitive failures that adversely affect plant availability, performance, capacity, quality, cost, or regulatory compliance
• Update: procedures, work instructions, guidelines, and testing documents such as installation / operational / verifications, standard operating procedures (SOP)
• Manage and source vendors to support qualifications, installations, calibrations, investigations, upgrades, preventive maintenance (PM), and/or repairs as needed
• Document and transfer knowledge to fellow engineers and laboratory operators
• Support the investigations in NCRs, CAPAs, and associated quality and technical investigations

Preferred Qualifications;

• 2+ years experience using an asset computerized maintenance management system (CMMS)
• 2+ years experience writing and executing windows based scripting language(s). 
• 2+ years experience troubleshooting and understanding the relationship between computer systems, hardware, software, networks, and telecommunications for storing, retrieving, transmitting, and manipulating data. 
• 1+ years experience in cross-functional project management and implementing new workflow processes. 
• 1 + years experience with data analysis techniques including statistical process control, OEE, reliability modeling and prediction, RCA techniques, and/or sig sigma methodology 

Required Skills;

• 2+ years of related experience with a BS/BA or higher degree in Engineering of equivalent work experience.
• 2+ years experience maintaining and writing/optimizing methods on automated liquid handling systems (e.g. MultiFlo/Bravo, STAR/STARlet, Echo, Lynx, Lunatic, high throughput NGS sequencers)
• 2+ years experience of technical writing within a regulated environment 
• 2+ years experience with Laboratory Information Management Systems (LIMS), Manufacturing Management Systems (MES), Customer Relationship Management (CRM) software
• 1+ years experience developing Powershell scripts for automation and windows-based environment solutions

Required Education;

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

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.