Senior Manager Manufacturing Systems - Automation Capital Projects

Amgen • Thousand Oaks, CA

2d

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Senior Manager Manufacturing Systems - Automation Capital Projects What you will do Let’s do this! Let’s change the world! In this dynamic role, as a member of the Amgen Manufacturing and Clinical Supply (MCS) – Facilities & Engineering (F&E) Automation team, you will lead a team of engineers supporting 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. You 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 for Amgen.

Requirements

• High school diploma / GED and 12 years of Engineering experience OR Associate’s degree and 10 years of Engineering experience OR Bachelor’s degree and 8 years of Engineering experience OR Master’s degree and 6 years of Engineering experience OR Doctorate degree and 2 years of Engineering experience
• In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.
• Your managerial experience may run concurrently with the required technical experience referenced above.

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 and Supply chain plant operations.
• 5 or more years of combined experience with the following automation systems:
• Emerson Delta-V DCS system.
• Rockwell Automation SCADA and PLC Platform.
• 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 with regulatory requirements such as 21 CFR Part 11, ASTM 2500, S88, S95, and GAMP.

Responsibilities

• Lead a team of Automation engineers responsible for supporting and delivering on complex capital construction projects, including Global Lifecycle Asset Management (GLAM) projects.
• Lead the direct reports, including External Workers (EWs), onboarding the EWs, and ensuring the direct reports’ adherence to Amgen training requirements.
• Represent Manufacturing & Clinical Plant Automation team during the development of project plan, business case, and cost estimates in partnership with key customers and stakeholders – ATO MCS Plant Operations, Engineering, Operations Information Systems (OIS), Global Construction Project Management (GCPM), and provide the necessary support to obtain funding approval.
• Based on project scope, work with Operations Technology (OT) teams to estimate labor hours and required resources for project funding.
• Work with diverse groups (Manufacturing, Quality, PD, Automation, IS, EHSS, Global Engineering) and drive new business processes to ensure continuous and sustained improvements.
• Represent Plant Automation team and participate in preparing and implementing detailed design, scope, and schedule in partnership with Engineering and GCPM.
• Ensure site readiness and compliance for internal audits, external agency audits, and partner audits relating to project delivery.
• Represent 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.
• Represent Plant Automation team during the post-implementation activities, including operationalizing 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.
• Represent Plant Automation team and support functional area projects focused on improving process equipment/utilities/facilities -to large/sophisticated capital projects to integrate new drug substance and drug product manufacturing technologies into clinical/commercial facilities.
• As applicable to the capital project scope, represent the Plant Automation team 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.
• Support a safe working environment in compliance with applicable environmental health/safety practices, rules, and regulations.
• Available for up to 10% domestic/international travel.

Benefits

• A 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
• Flexible work models where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: High school or GED