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This role will serve as a process equipment system owner for the Chemical Synthesis API Manufacturing Facility in ASM for the facilities and engineering team. The role will be a liaison between manufacturing, maintenance, engineering and automation in the troubleshooting and resolution of equipment related issues. Experience in design, qualification, operation, maintenance and improvement of Chemical Synthesis API process equipment will be required to support day to day manufacturing activities as well as to lead improvement projects. Overall Chemical Synthesis processes knowledge will be required to perform complex troubleshooting activities. This role is crucial for Amgen’s success and it will be a key contributor in the ASM- Chemical Synthesis API Manufacturing Facility. This role will partner with vendors/networks to determine innovative opportunities to improve the site’s reliability, efficiency, agility and differentiation.
Job Responsibility:
Serve as a process equipment system owner for the Chemical Synthesis API Manufacturing Facility
Be a liaison between manufacturing, maintenance, engineering and automation in the troubleshooting and resolution of equipment related issues
Lead and participate in the investigation and troubleshooting of process equipment related issues
Identify effective recommendation on corrective actions, preventive actions and improvements
Effectively communicate and collaborate with cross function stakeholders to address operational challenges and concerns to ensure sustained operation and minimal interruptions
Provide technical expertise in operational continuous improvement projects or initiatives (yield improvements, risk mitigation, capacity expansion etc.)
Participate in design review and set up of new asset and associated maintenance plan/spares in Maximo
Participate in commissioning and qualification activities such as IOQ protocol/report review and approval, FAT, SAT, PSSR
Work with stakeholders to develop requirements and implement equipment / facility modifications
Develop technical solutions to problems requiring the regular use of ingenuity and creativity
Continuously improve Business Intelligence capabilities (e.g., ability to extract, manipulate, analyze and trend performance data)
Benchmark equipment performance (e.g., reliability, productivity) and ident improvement plans
Assess predictive technologies for implementation
Requirements:
Master’s degree OR Bachelor’s degree and 2 years of directly related experience OR Associate’s degree and/or 6 years of directly related experience OR High school diploma / GED and 8 years of directly related experience
Working experience in process engineering team in chemical synthesis API manufacturing
Established expertise in at least 2 separate areas of engineering technology such as equipment design/operation/maintenance, automation, process engineering, project management and/or validation
Demonstrated project management skills (schedule/cost development, facilitation, collaboration, basic project management, completion and follow-up) and application of concepts
Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach
Good communications skills, both oral and written, including presentation skills
Interpersonal and facilitation skills necessary to forge consensus among competing client interests while ensuring objectives are met
Strong analytical skills and knowledge of industry trends to identify potential improvement opportunities
Ability to combine technical problem-solving skills with business acumen to identify best business solution
Nice to have:
Working knowledge of high potency active pharmaceutical ingredient (API) processes involving equipment such as Glass lined reactors, Filter dryer, Isolators and critical utilities such as TCU and Scrubber will be an added advantage
Knowledge of Operational Excellence practices such as lean manufacturing and lean maintenance is a plus
What we offer:
Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits