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Senior Automation Engineer

Company: LGC Limited
Location: Novato
Posted on: January 9, 2021

Job Description:

Position Summary:The Senior Automation Engineer will lead the efforts for expansion and modernization of laboratory automation, build automation expertise within the manufacturing team, develop, maintain, and oversee current automated methods, assays and instruments. The ideal candidate will have a track record of accomplishments in a start-up, pharmaceutical, or biotech environment. The successful candidate must have a background in liquid handling and laboratory automation with previous demonstrated experience in methods development and assay automation. This role requires practical knowledge of Tecan and/or Beckman Coulter liquid handlers (EVO, FX/NX) and associated software. The position requires a broad range of disciplines, including project management, mentoring, troubleshooting, developing protocols, liquid handling, and method validation/verification.Areas of Responsibility:* Lead the design, commissioning, and implementation of automation engineering projects in the GMP manufacturing areas and supporting labs.* Provide hands-on technical support, diagnostics, and troubleshooting functions to manufacturing operations.* Investigates deviations and applies root cause analysis tools to determine root cause(s) and establishes resolution/implementation of CAPA's to minimize repetitive deviations.* Develops and executes short-term and long-term plans to implement corrective actions for Automation based atypical events.* Mentor and train laboratory staff on automated liquid handlers use, software, and process.* Work effectively with multi-disciplinary groups and individuals to implement solutions that support operational efficiencies in terms of throughput, OTD, cost, health, and safety.* Act as project manager and SME for small and large scale projects. Manage, plan, develop, and execute laboratory automation projects from start to completion.* Establish, monitor and maintain a stable and productive automation environment through process monitoring, QC, IQ/OQ/PQ, and preventative maintenance plans. Utilize statistical tools to analyze process data to ensure process is in control and capable.* Develop and execute validation protocols.* Write technical reports and/or presentations relevant to processing activities and present to various levels of management and regulatory authorities.* Develop and maintain operational SOPs for automation systems and processes.* Develop and maintain system lifecycle documentation for automation systems.* Performs risk assessments/ recommendations. Assists with equipment failure risk mitigation, FMEA analysis, and process safety assessments.* Supply regular feedback to management on the status of instrumentation and processes.Other Skills and Abilities:* Professional presence and strong attention to detail* Superior oral/written communication and problem solving skills* Mentoring and/or leadership experience* Direct experience with one or more liquid handling platforms such as Tecan, Hamilton, or Beckman, including programming/scripting fluency.* Demonstrated familiarity with contemporary molecular genomic technologies.* Strong understanding of and experience with ISO 13485, cGMP, and 21 CFR Part 11 regulatory environments and guidelines.* Technical proficiency and experience in automation, systems development, and integration for the life science industry; especially with robotics and liquid handling systems.* Ability manage multiple and changing priorities while maintaining project timelines that serve business needs.* Strong collaborative work ethic; must be a self-starter and persistent in achieving objectives to support business goals.CA1QualificationsEducation/Experience:A minimum of a Bachelor's degree in the Life Sciences or Engineering discipline, 5+ years of industry experience in a similar position and/or demonstrates proficiency to meet the requirements of a Senior Automation Engineer.Mathematical Skills:Ability to add, subtract, multiply, and divide all units of measure, using whole numbers, common fractions, decimals, and statistical calculations.Computer Skills:Microsoft Office, Outlook, Word, PowerPoint and Excel. Use of a web browser. Proficiency in one or more programming languages.

Keywords: LGC Limited, Novato , Senior Automation Engineer, Engineering , Novato, California

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