Senior Manufacturing Systems Engineer (Rockwell, Siemens, and B&R)

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.

Responsibilities

• Develop, organize, analyze and present interpretation of results for operational issues or engineering projects of significant scope and complexity.
• Complete sophisticated or novel assignments requiring development of new and/or improved engineering techniques and procedures.
• Develop detailed specification and engineering policies and procedures that affect multiple organizational units.
• Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.
• Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility modifications.
• Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.
• Coordinate the work of consultants, architects and engineering firms on development of standard design documents.

Requirements

• Doctorate degree or Master's degree & 2 years of engineering experience in a GMP environment or Bachelor's degree & 4 years of engineering experience in a GMP environment or Associate degree & 8 years of engineering experience in a GMP environment or High school diploma / GED and 10 years of engineering experience in a GMP environment.

Nice-to-haves

• Advance degree in Computer, Electrical, Mechanical, Chemical Engineering, or Biomedical Engineering.
• Knowledge and/or experience of pharmaceutical/biotech processes, especially in the area of final drug product operations.
• Knowledge in Data Integrity and Security.
• Extensive understanding and background in programming, design, installation, validation, and lifecycle management of manufacturing process controls, automation, field instrumentation technologies.
• Expertise in Machine Vision (Cognex) and Rockwell software platform.
• Knowledge in Deep Learning.
• Direct experience with leading and managing Systech Serialization projects including experience with Guardian, Advisor, Sentri, and other Systech ancillary devices.
• Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment.
• Comprehensive understanding of validation protocol execution requirements as well as knowledge of validation processes and requirements as applied to new equipment installations.
• Excellent communication skills together with ability to work in a team environment.
• Organizational, project management, problem-solving, as well as validation protocol and technical writing capability.
• Track record of leading and executing multi-functional projects.
• Strong teamwork, excellent interpersonal and communication skills.
• Direct experience with medical devices/combination products and associated manufacturing processes.
• Experience in working with third-party vendors and equipment suppliers.
• Ability to work in a highly regulated and ever-changing industry.
• Ability to learn and rapidly adapt to new requirements in a fast paced environment.
• An Operational Excellence and Lean Transformation approach to work product - driving rapid results.
• A passion to deliver an excellent work product and develop others with an infective positive attitude!

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.

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