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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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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.
Job Responsibility:
Support system reliability and operational optimization efforts
Identify system performance risks (e.g. single point of failure or obsolescence) and implement risk reduction strategies
Lead and execute improvement efforts, including identifying cycle reduction time opportunities, efficiency gains, and yield improvement opportunities
Support technical investigations, root cause analysis, and equipment troubleshooting activities
Apply structured problem-solving methodologies with guidance
Analyze data and assist in developing engineering solutions using data techniques and methodologies (e.g. Statistical Process Control, Six Sigma, predictive maintenance analysis, etc.)
Support new product and technology introductions by assisting with engineering assessments, equipment modifications, and execution of engineering runs
Collect, organize, analyze, and present results for operational issues and engineering projects of small scope and complexity
Provide onsite day-to-day technical support for equipment and process troubleshooting
Apply process engineering principles to support the design, specification, installation, startup, and validation of process equipment and systems
Assists with project activities by performing engineering studies and assessments for process equipment systems
Translate user and process requirements into engineering documentation and support design development in alignment with standard engineering practices
Communicate effectively with supervisors, cross-functional teams, and support staff to escalate issues and contribute to solutions
Support a safe working environment by aligning with all pertinent environmental health/safety practice, rules and regulations
Requirements:
Master’s degree 2 years of Engineering experience
OR Bachelor’s degree and 4 years of Engineering experience
OR Associate’s degree and 6 years of Engineering experience
OR High school diploma / GED and 8 years of Engineering experience
Nice to have:
Bachelor’s degree in Chemical Engineering, Mechanical Engineering, or Bioengineering preferred
Direct experience with regulated environments (e.g. FDA, cGMP, OSHA, EPA, etc.) is preferred
Subject Matter Expert and hands-on experience with complex manufacturing process equipment including sophisticated troubleshooting, reliability and performance improvements, and design optimization
Direct experience in equipment engineering and problem solving for cleaning, centrifuges, chromatography systems, and/or filtration systems
Have a foundational knowledge of Maximo or equivalent Asset Management System for managing equipment maintenance and asset lifecycle
Solid understanding and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment
Experience supporting design and startup engineering directly related to bulk biopharmaceutical production including process equipment and facilities design, procurement, construction, startup, and validation is preferred
Demonstrates independence, strong self-motivation, and organization, with the ability to manage multiple priorities in a project-based environment
effective in communication, facilitation, and collaboration
Demonstrates a strong team-oriented mindset and actively contributes to a collaborative culture that supports effective decision-making
Applies a continuous improvement mindset in daily activities and promotes a strong commitment to safety in all aspects of work
Ability to apply sophisticated and diverse engineering principles to the design and implementation of major system modifications, introduction of new equipment, processes, and capital projects
Develops contingency plan for potential obstacles or setbacks
Mentorship experience with peers or new team members on complex systems, equipment, machines, and/or processes within their area of expertise
Demonstrates interest in continuous learning opportunities around new tools, techniques, and configurations to enhance their analytical abilities
Strong leadership, technical writing, and communication/presentation skills are required
Required flexibility to support 24/7 operations, including scheduled weekend shifts, after-hours coverage, and on-call rotation
What we offer:
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