Career Category

Job Description

Role Description

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics has changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives.

Responsibilities

Daily Operations:

• Subject matter expert for process equipment performance and operation to ensure safety, compliance and sustained operation.

• Effectively communicate and collaborate with cross function stakeholders to address operational challenges and concerns to ensure sustained operation and minimal interruptions to operations activities.

• Lead and participate in equipment breakdown investigations to identify root causes. Effectively communicate to the customers on the subsequent plans, short term and long term mitigating actions.

• Collaborate closely with cross functional SME to implement effective corrective, preventive action and improvements to eliminate or mitigate future recurrence.

• Ensure operation continuity through asset lifecycle management planning, assess and identify impact to safety, compliance, operational schedule and cost.

• Perform assessment for equipment during new product introduction, change controls and other qualifications activities to ensure equipment are in its validated state.

Continuous improvements, Innovation and operational sustainability:

• Participate in related AMGEN network forums to determine innovative opportunities to improve reliability, efficiency, agility and differentiation.

• Continuously improve business intelligence capabilities utilizing big data analysis tools to extract, analyze and trend performance data for predictive monitoring and troubleshooting.

• Actively seek opportunities for continuous improvement to improve efficiencies and differentiation through flexible use of new technologies and best industry practices.

• Benchmark equipment performance (e.g. reliability, productivity) and determine improvement plans.

• Periodically review and/or improve equipment safety, maintenance strategy, spare parts and other continuous improvement opportunities to enhance reliability.

Organization Leadership

• Develop the best team by coaching and mentoring engineers to develop their technical competency and leadership skills.

• Work in teams by educating customers on lesson learns, collaborate with customers managers to identify knowledge or trainings gaps.

• Deliver strong result in the right way by consciously being a role model that ensure results are deliver without compromising on core AMGEN values.

Basic Qualifications

• Master’s degree in Engineering and 5 years of experience in pharmaceutical company or GMP environment OR
• Bachelor’s degree in Engineering and 8 years of experience in a pharmaceutical company or GMP environment

Preferred Qualifications

• Able to work independently with minimal of no supervision.
• Experience in managing various stakeholders expectations related to process equipment in biopharmaceutical.
• Good communications skills, both oral and written, including presentation skills. Good 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 determine best business solution.
• Working knowledge of biopharmaceutical processes such as inoculation, bioreactors, harvest is preferred. Process knowledge on chromatography, buffer / media tanks, viral filtration, tangential flow filtration, single use technologies and critical utilities will also be considered.
• Experience in validation processes such as generation/execution of Installation/Operation/Performance qualification documentation.