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Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

Principal Automation Engineer

Live

What you will do

Let’s do this. Let’s change the world. In this dynamic role you will implement strategic development of automation technologies for Amgen. The team will design, develop, and deliver innovative solutions enabling the advancement and intensification of Amgen processes. Responsibilities include:

• Develop and maintain process control automation solutions utilizing DeltaV Distributed Control System (DCS), Rockwell Programmable Logic Controllers (PLC), Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA).
• Lead and support functional area projects focused on improving process equipment/utilities/facilities -to sophisticated unit operation skids to integrate new drug substance manufacturing technologies into clinical/commercial facility.
• Collaborate with vendors to design automated process equipment and compliant manufacturing software for systems that are novel to the industry and/or new to Amgen manufacturing operations.
• Network internally and externally to define problem statements and identify key technologies and potential solutions in the advanced automation and process control field.
• Plan and implement major change efforts for automation strategy for the company, beginning in the Manufacturing and Clinical Supply (MCS) organization.
• Lead/support technical root cause analysis, incident investigations, and solving problems related to process control issues within plant operations.
• Lead and 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

Develop business case and resource estimate. Define the strategy for automation and process control within advanced bioprocessing operations. Partner with senior management within Process Development to secure resources for programs of critical importance. Lead the team implementing the development strategy. As part of the Facilities & Engineering (F&E) group within the Manufacturing Clinical Supply (MCS) organization, the This role is expected to provide leadership as follows:

• Serve as an experienced advisor to senior level management and ensure the automation development strategy aligns with Amgen Process Development strategy.
• Partner with Process Development scientists, Amgen IS, and commercial manufacturing teams to ensure compliant delivery of developed solutions.
• Strategic and tactical management and leadership in providing operational support, next generation technology development and project support, mentoring, staff development, team productivity, and efficient use of available resources.
• Develop support structures with internal/cross-functional teams for capital projects, pilot plant support, and Amgen network-level initiatives execution.
• Providing input into department objectives and establishing strategic direction within the Drug Substance Pilot Plant Network F&E automation team.
• Maintain and improve Network capabilities and automation systems reliability in partnership with F&E and plant leadership and other technical staff in the network, focusing on “predict and prevent” systems failures and recurrence avoidance. Strategize asset lifecycle management and long-range plans for equipment Maintenance.
• Work with diverse groups (Manufacturing, Quality, PD, Automation, IS, EHSS, Global Engineering) and drive new business processes to ensure continuous and sustained improvements. Translate business needs into engineering technology solutions. Lead analysis of alternatives and recommendations for technical/business proposals.
• Identify areas of potential improvement, conduct analyses, recommend solutions, sponsor improvement projects and implement.
• Ensure site readiness and compliance for internal audits, external agency audits, and partner audits. Ensure the safety of all personnel during plant operations and engineering activities.
• Ensure that all staff are adequately trained and follow all GMP standards and procedures
• Ensure Business Continuity, identify gaps and develop/implement solutions to close the gaps.
• Develop and adhere to department budgets and spend for operational and capital expenses.
• Be knowledgeable about compliance and regulatory aspects for operation and maintenance, equipment validation, and support regulatory inspections and audits.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Engineering professional we seek is a collaborative partner with these qualifications.

Basic Qualifications:

• Doctorate degree and 2 years of Engineering experience OR Master’s degree and 6 years of Engineering experience OR Bachelor’s degree and 8 years of Engineering experience OR Associate’s degree and 10 years of Engineering experience OR High school diploma / GED and 12 years of Engineering experience.
• 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or advising the allocation of resources

Preferred Qualifications:

• Ph. D. in Chemical Engineering, Electrical Engineering, or related field.
• 10-15 years experience working in the process automation field within the biopharmaceutical industry.
• Ability to work independently and in small groups.
• Demonstrated proficiency in implementation of advanced process control applications in an industrial setting (e.g. Model Predictive Control, Adaptive Control).
• Familiarity with multivariate statistics and linear systems theory.
• 5-10 years experience as an engineer or system administrator within the DeltaV Distributed Control System.
• Greater than 4 years proven experience leading matrixed teams.