Sr. Mfg Systems Engineer- Automation

$129,515 - $151,086/Yr

Amgen - Thousand Oaks, CA

Full-time - Mid Level

Remote - Thousand Oaks, CA

10,001+ employees

Chemical Manufacturing

About the position

In this role as a member of the Amgen Manufacturing & Clinical Supplies Facilities & Engineering (MCS-F&E) Automation team, you will support Clinical & Commercial Drug Product Plant Automation. This includes sophisticated and complicated system automation initiatives that require a proven understanding of various automation platforms, integration between different platforms, analytical problem-solving techniques, critical thinking, project management, lifecycle management, and Operational Excellence. You will be responsible for developing and maintaining process control automation solutions using Rockwell and Siemens Programmable Logic Controllers (PLC), Human Machine Interfaces (HMI), and Supervisory Control and Data Acquisition systems (SCADA). Your role will also involve supporting functional area projects focused on improving process equipment, utilities, and facilities, as well as integrating new drug product manufacturing technologies into clinical and commercial facilities. You will lead and support technical root cause analysis, incident investigations, and problem-solving related to process control issues within plant operations. Additionally, you will support new product introductions (NPI) or new technology introductions by performing automation engineering assessments, implementing automation system configuration changes, and supporting engineering and process qualification runs as applicable. Continuous Improvement initiatives will be a key part of your responsibilities, including Safety, Reliability, Efficiency, and Environmental sustainability improvements to meet Amgen's goals. You will also maintain Data Integrity Assessments in line with current Amgen and Industry standards and collaborate with the Amgen Drug Product Plant network to improve automation design for ATO Drug Product Plant Operations. Your day-to-day operational support will include 24 x 7 Onsite/On Call support, troubleshooting support to manufacturing operations, automation system administration, and managing automation system operating systems and HotFix assessments. You will participate in daily manufacturing and engineering work center team meetings, preventative and corrective maintenance, and automation system spare parts management. Driving true root cause investigations and resolutions by collaborating with equipment vendors will also be part of your role, along with business process improvements including departmental Standard Operating Procedures (SOP).

Responsibilities

• Develop and maintain process control automation solutions applying Rockwell and Siemens Programmable Logic Controllers (PLC), Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA).
• Support functional area projects focused on improving process equipment/utilities/facilities and integrating new drug product manufacturing technologies into clinical/commercial facilities.
• Lead/support technical root cause analysis, incident investigations, and solving problems related to process control issues within plant operations.
• Support new product introductions (NPI) or new technology introductions by performing automation engineering assessments, implementing automation system configuration changes, and supporting engineering and process qualification runs as applicable.
• Provide Continuous Improvement initiatives including Safety, Reliability, Efficiency and Environmental sustainability improvements to meet Amgen's goals.
• Maintain Data Integrity Assessments with the current Amgen and Industry standards.
• Collaborate with Amgen Drug Product Plant network to improve the automation design for ATO Drug Product Plant Operations.
• Provide day-to-day operational support including 24 x 7 Onsite/On Call support, troubleshooting support to manufacturing operations, and automation system administration.
• Manage automation system operating systems (OS) and HotFix assessments and rollout.
• Participate in daily manufacturing and engineering work center team meetings, preventative and corrective maintenance, and automation system spare parts management.
• Drive true root cause investigations and resolutions by collaborating with equipment vendors.
• Implement business process improvements including departmental Standard Operating Procedures (SOP).

Requirements

• Doctorate degree in a relevant field or a Master's degree with 3 years of Manufacturing Automation Engineering experience or a Bachelor's degree with 5 years of Manufacturing Automation Engineering experience or an Associate degree with 10 years of Manufacturing Automation Engineering experience or a High school diploma / GED with 12 years of Manufacturing Automation Engineering experience.
• Degree in Electrical Engineering, Computer Science, Chemical Engineering, or Biotech is preferred.
• Extensive understanding and background in programming, design, installation, and lifecycle management of manufacturing process controls, automation, and field instrumentation.
• Demonstrated hands-on experience in developing process control strategies for New Product.
• Direct knowledge of Automation design, experience in process control engineering, and solving problems with GMP biopharmaceutical production facility equipment/systems, and integrating various OEM automation software.
• Demonstrated experience with continuous improvements resulting in enhanced safety, system reliability, and efficiency related to Drug Product Plant Operations.
• Experience in Capital Project Lifecycle Management including conceptual design, scope and cost estimate development, case development, detailed design, engineering and validation documentation, and project leadership is a plus.
• Strong leadership, technical writing, and communication/presentation skills. Ability to perform independently, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and teamwork.
• 4+ years combined experience with Rockwell Automation SCADA and PLC Platform, Siemens SCADA and PLC Platform, iFix SCADA Platform, Electronic Batch Reporting Systems Design and implementation, Process Control Network design, Process Control Systems, and System Integration using OPC, ETHERNET/IP technologies.

Nice-to-haves

• Knowledge of ODBC and RDBMS interfaces.
• Compliance and regulatory requirements such as 21 CFR Part 11, ASTM 2500, S88, S95 and GAMP.
• Knowledge of Custom-Off-the-shelf (COTS) Drug Product unit operations such as Lyophilizer, Vial Filler, Vial Washer, Capper, Depyrogenation oven, Tray Loader.

Benefits

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
• Stock-based long-term incentives.
• Award-winning time-off plans and bi-annual company-wide shutdowns.
• Flexible work models, including remote work arrangements, where possible.