Senior Process Engineer - Systems #4072

Responsibilities

• Lead multiple systems to support internal Equipment Program processes and procedures.
• Apply analytical thinking skills to diagnose, make recommendations, and implement systems.
• Incorporate knowledge of business and technology and develop and lead implementation of plans for approved solutions.
• Translate data gathered from user discussions into business requirements.
• Identify business/system needs and lead solutions.
• Lead, implement, and execute testing strategies and develop preliminary findings.
• Support multiple systems performance and reliability.
• Prepare reports, metrics, and other tracking tools measuring / allowing for success.
• Actively represent areas in audits.
• Execute timely processing of investigations, impact assessment, Change Controls, NCRs, deviations, and CAPAs.
• Execute analysis of data from multiple sources and help the team balance efficiency, cost of goods, and system uptime while maintaining a safe and compliant work environment.
• Update, maintain, and execute, test plans, user manuals, process flow charts, software qualification, engineering reports, verifications, work instructions, and standard operating procedures (SOPs) as needed.
• Provide technical training, create new training, and transfer knowledge to fellow engineers and operators.
• Participate and adhere to GRAIL’s policies and guidelines.
• Recommend and implement changes to ensure ongoing high-quality performance of engineering systems as part of the continuous improvement process.
• Lead and execute identification of and solutions to the root cause of process discrepancies, deviations and non-conformances.

Preferred Qualifications:

• 5+ years of related experience with a BS/BA or higher degree in Engineering or equivalent work experience
• 3+ years working with equipment and systems.
• 3+ years in data management
• 2+ years experience in data entry / analytics development
• 2+ years in design experience of systems infrastructure
• 1+ years usage of Asset Management Lifecycle
• 1+ year working knowledge of IT networking and systems infrastructure.
• 1+ year experience in Project Management preferably utilizing Agile methodologies (e.g., Scrum, Kanban) to iteratively plan, execute, and optimize tasks
• Excellent problem solving, analytical, root cause analysis, and troubleshooting skills
• Excellent communication skills to work independently and provide internal customer support
• Excellent time management skills to support a fast paced working environment
• Excellent knowledge writing and executing SOP’s, Work Instructions, or Test Protocols
• Ability to take initiative and independently drive projects to completion with detailed and efficient execution and reporting
• Experience working under cGxP (Documentation, Manufacturing, Automation Manufacturing, Laboratory) ISO 13485 or FDA regulated environment
• Excellent technical troubleshooting skills and logic proficiency
• Excellent problem solving and analytical skills
• Experience with Environmental Monitoring Systems
• Experience with Enterprise Asset Management Systems (HxGN EAM preferred)
• Knowledge of PL/SQL, Python, JSON, RESTful API integration, and/or Middleware is highly desirable
• Ability to travel up to 10% of the time

Physical Demands & Working Environment

• Hours and days may vary depending on operational needs
• Regularly required to stand, sit, walk, climb stairs/ladders, kneel, crouch, or wear safety gear.
• Must regularly lift and / or move up to 10 pounds.
• Frequently lift and/or move up to 25 pounds.
• Occasionally lift and/or move up to 50 pounds.
• Working with dry ice may be necessary.
• Working on confined spaces may be necessary
• May be exposed to hazardous materials, blood specimens and instruments with moving parts, heating or freezing elements, and high speed centrifugation.