Principal Engineer, Biotech Facilities & Engineering (JP15096)

3 Key Consulting • Thousand Oaks, CA

31d

About The Position

3 Key Consulting is hiring! We are recruiting a Principal Engineer for a consulting engagement with our direct client, a leading global biotechnology company. Ideal candidate: Must have background in within Life sciences specifically Biotechnology and Biomedical Engineering. Emerson Delta-V DCS Programming Experience, Rockwell Automation SCADA and PLC Experience, Compliance with regulatory requirements such as 21 CFR Part 11, Minimum of Bachelors Degree in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering, or related life science engineering. The company Manufacturing and Clinical Supply (MCS) – Facilities & Engineering (F&E) Automation team, is looking for Engineers to support Clinical & Commercial Plant Automation programs and Capital projects, including complex and challenging automation initiatives that require a solid understanding of various automation platforms, integration between different platforms, analytical problem-solving techniques, project management, product lifecycle management, and operational excellence. They will require an extensive understanding and background in capital construction projects, design, programming, implementation, and lifecycle management of manufacturing process controls, automation, and field instrumentation technologies.

Requirements

• Must have background in within Life sciences specifically Biotechnology and Biomedical Engineering.
• Emerson Delta-V DCS Programming Experience
• Rockwell Automation SCADA and PLC Experience
• Compliance with regulatory requirements such as 21 CFR Part 11
• Minimum of Bachelors Degree in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering, or related life science engineering.
• Must have direct programming experience in Rockwell and/or Emerson and/or HMI and/or Allen Bradley
• Life Sciences GMP experience
• Experience with supporting automation capital projects (qualification, testing)
• Masters degree and 5 years of experience OR Bachelors degree and 7 years of experience OR Associates degree and 12 years of experience OR High school diploma / GED and 14 years of experience

Nice To Haves

• Degree in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering, or related life science engineering.
• Knowledge and experience in capital project lifecycle management including conceptual design, scope, resource estimate & cost estimate development, business case development, detailed design, engineering, commissioning, validation, and project execution, as it relates to Plant Automation and process control systems with GMP biopharmaceutical production facility equipment/systems in support of Drug Substance, Drug Product plant operations.
• Has five or more years combined experience with the following automation systems: Emerson Delta-V DCS system. Rockwell Automation SCADA and PLC Platform. ABB Robot and Mitsubishi roller bottle machine Emerson Delta-V DCS system. Electronic Batch Reporting Systems Design and implementation experience.
• Process Control Network design including network segregation.
• Process Control Systems: Virtual Infrastructure design and implementation.
• System Integration using OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies.
• Compliance to regulatory requirements such as 21 CFR Part 11, ASTM 2500, S88, S95 and GAMP.

Responsibilities

• Support automation capital project software development testing, commissioning activities etc.
• Support day to day operations of the plant for automation related issues including on call rotation every 7-8 weeks.
• Support Plant Automation team and participate in the preparation and implementation of detailed design, scope, schedule in partnership with cross functional teams.
• Support Plant Automation team during the project implementation of new automation solutions including DeltaV Distributed Control System (DCS), Rockwell Programmable Logic Controllers (PLC), Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA) related hardware, software, network infrastructure, and electronic Rt-reporting scope across various projects.
• Support Plant Automation team during the post-implementation activities including operationalization of the new assets by extending hyper-care support, training the System Owners, and Manufacturing team, revising the SOPs, and training documents, delivering spare parts list, updating Maximo assets and Amgen CMDB systems.
• Ensure compliance to Amgen Engineering and Operational standards, specifications, and procedures as applicable during the project design and implementation.
• As applicable to the capital project scope, represent Plant Automation team and support new continuous improvements by performing automation engineering assessments, implementing automation system configuration changes, and supporting engineering and process qualification runs.
• Support a safe working environment by complying with all pertinent environmental health/safety practice, rules, and regulations.

What This Job Offers

• Career Level: Principal