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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
Provide system ownership for Clean and Plant Utility systems and equipment supporting operations at the site
Provide engineering support for design, construction, startup, commissioning and qualification of new or modified systems
Identify, support, and/or lead implementation of engineering-based improvements or upgrades in small to medium scope and complexity to the equipment or facility systems
Lead the development of a business case if required to support the completion of the project
Develop equipment maintenance programs, ensure the availability of spare parts, and coordinating maintenance execution as necessary to ensure systems are in proper working order
Ensure systems are installed and operating safety and comply with pertinent environmental health/safety practice, rules and regulations
Ensure necessary commissioning and qualification of systems is completed in alignment with GMP requirements and interact with regulatory inspectors as necessary
Apply basic engineering principles and practices in support of daily operation, maintenance, and troubleshooting of plant systems
Monitor systems to identify performance risks and implement risk reduction strategies
Providing troubleshooting support to reduce production downtime
Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs
Advance the use of condition based and predictive maintenance practices by incorporating advanced data analytics where applicable
Own investigations of abnormal conditions through Deviation and business processes
Requirements
High school diploma / GED and 10 years of Engineering/Maintenance experience
OR Associate's degree and 8 years of Engineering/Maintenance experience
OR Bachelor's degree and 4 years of Engineering/Maintenance experience
OR Master's degree and 2 years of Engineering/Maintenance experience
OR Doctorate degree
Nice to have
Bachelor's degree in Chemical, Mechanical, or Electrical Engineering
4+ years of relevant work experience with 2+ years experience in Biopharmaceutical operations/manufacturing environment
Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility utility equipment/systems such as Pharmaceutical Water, Clean Steam, and Clean Air generation and distribution
and as well as other Plant Utility equipment needed to support these processes such as Chilled Water chillers, cooling towers, steam boilers, air compressors, etc.
Experience with equipment and facility control systems operation, logic, and troubleshooting
Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Data Analytics, Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)
Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects
Understanding of the execution process of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation
Understanding of safety requirements working in a GMP Biopharmaceutical Production facility
Independent, ambitious, organized, able to multi-task in project environments, and skilled in communication, facilitation, and teamwork
Great teammate prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making
Strong leadership, technical writing, and communication/presentation skills
Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage
Ability for domestic/international travel
What we offer
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
Discretionary annual bonus program or sales-based incentive plan