Senior Manufacturing Systems Engineer

Amgen • Holly Springs, NC

17d

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 Manufacturing Systems Engineer What you will do Let’s do this. Let’s change the world. In this vital role you will be part of Amgen's most technologically advanced drug substance manufacturing plant. The facility continues to expand in size and advance with embedded new technologies and industry 4.0 capabilities facility wide. As a Senior Manufacturing Systems Engineer, you will: Work with process subject matter experts (SMEs) to understand key process requirements and transform them into digital automated solutions. Collaborate with business partners to understand how automation can improve workflow and productivity. Synthesize requirements from clients, customers or end-users to develop the best automation solutions. Lead and support functional area projects focused on improving process equipment/utilities/facilities as well as large/sophisticated capital projects to integrate new drug substance manufacturing technologies into the facility 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. Build the business processes to support the project scope in alignment with project timelines. Develop detailed specification and engineering policies and procedures that affect multiple organizational units. Provide clear documentation for delivered solutions and processes; work closely with QA partners while supporting computerized systems validation processes in a GxP environment. Ability to anticipate, evaluate and resolve project issues, delays, and problems by using technical, project management, and business expertise. Manage multiple initiatives and priorities. Be constantly curious and feed your passion and interests in groundbreaking technology. Use your given time to look for new and innovative ways to do business differently, better, and more cost effectively What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek will have these qualifications.

Requirements

• Doctorate degree OR Master's degree and 2 years of Manufacturing Process automation/Information system experience OR Bachelor's degree and 4 years Manufacturing Process automation/Information system experience OR Associate's degree and 8 years of Manufacturing Process automation/Information system experience OR High school diploma / GED and 10 years of Manufacturing Process automation/Information system experience

Nice To Haves

• Demonstrable experience in a manufacturing environment with ability in the Pharmaceutical or Biotechnology industries.
• Direct knowledge of Automation design, experience in process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems such as media, harvest, bioreactors, chromatography, vial filtration, and ultrafiltration/diafiltration, and integrating various OEM automation software packages.
• Extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls, automation and field instrumentation technologies.
• Experience with Emerson Delta-V DCS system, Process Control Network design including network segregation, and Process Control System Virtual Infrastructure design and implementation.
• Demonstrable understanding of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards and methodologies to establish a PCS and MES implementation and Systems Integration that meets Operations' business requirements.
• Experience in Capital Project Lifecycle Management: Conceptual Design, Scope and cost estimate development, business case development, detailed design, engineering and validation documentation and project execution.
• Demonstrated hands-on experience in developing process control strategies for New Product Introduction and New Technology Deployment for Drug Substance Plant Operations.
• Position requires an in-depth knowledge and hands-on coding experience of Emerson Delta V Platform in particular, and on Rockwell FactoryTalk, Rockwell PLC’s.
• Aveva PI Data Historian knowledge is preferred.
• Kneat platform-based C&Q documentation development knowledge a plus
• The ideal individual must be a self-directed team player ready to mentor and develop engineering staff and embrace a team-based culture that relies on collaboration for effective decision-making.
• Strong leadership, technical writing, and communication/presentation skills.

Responsibilities

• Work with process subject matter experts (SMEs) to understand key process requirements and transform them into digital automated solutions.
• Collaborate with business partners to understand how automation can improve workflow and productivity.
• Synthesize requirements from clients, customers or end-users to develop the best automation solutions.
• Lead and support functional area projects focused on improving process equipment/utilities/facilities as well as large/sophisticated capital projects to integrate new drug substance manufacturing technologies into the facility
• 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.
• Build the business processes to support the project scope in alignment with project timelines.
• Develop detailed specification and engineering policies and procedures that affect multiple organizational units.
• Provide clear documentation for delivered solutions and processes; work closely with QA partners while supporting computerized systems validation processes in a GxP environment.
• Ability to anticipate, evaluate and resolve project issues, delays, and problems by using technical, project management, and business expertise.
• Manage multiple initiatives and priorities.
• Be constantly curious and feed your passion and interests in groundbreaking technology.
• Use your given time to look for new and innovative ways to do business differently, better, and more cost effectively

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, including remote and hybrid work arrangements, where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees