Career Category
EngineeringJob 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.
As an Automation Engineer, you will be responsible to provide engineering subject matter expertise support to the manufacturing plants, utilities and site facilities operation to ensure consistent product supply and deliver production target. You will be entrusted with the responsibility to ensure maximum plant capabilities through continuous improvement so that equipment and facilities will be optimized in accordance to Good Manufacturing Practice, Good Engineering Practice and in compliance with regulatory requirements as well as EHSS requirements.
Responsibilities
Lead operational plant troubleshooting efforts and investigation of production process, equipment, systems and code/configuration
Provides support for the development of new product launch, new capabilities and optimization operational project initiatives to facilitate technical transfer of new program into manufacturing and provide the automation solution
Provides technical support for new equipment/process start-ups and operation
Provide operational support to the GMP processes including some off-hours on-call support
Perform Root Cause Analysis, develop corrective and preventive actions and develop technical solutions to prevent recurrence
Make changes to manufacturing process control under strict GMP change control management process to optimize processes and maintain compliance
Responsible for the execution of all design, build and run activities
Ensure robust testing of new configuration features based on structure risk assessments
Work closely with stakeholder to ensure production supply
Collaborate with cross functional team to resolve incidents, events or deviations
Update or develop standard operating procedures, work instructions, functional / design specifications associated with automation process control.
Promote Safety, Quality and Compliance culture and continuous improvement mindset that lead to plant safety, quality and compliance to regulatory requirement
Support engineering process performance management, audit and inspection
Provide training to plant personnel on automation control process
Support Service Owner and System Owner roles for DeltaV at ASM
Basic Qualifications
Bachelor’s degree in Engineering, Information Systems, Computer Science, or Life Sciences and 2 years of directly related experience
Associate’s degree in Engineering, Information Systems, Computer Science, or Life Sciences and/or 4 years of directly related experience
High school diploma in Engineering, Information Systems, Computer Science, or Life Sciences / GED and 8 years of directly related experience
Knowledge of DeltaV DCS is a must
Preferred Qualifications
4+ years’ experience in manufacturing automation, particularly in biotechnology or pharmaceutical industries
Hands on experience with automation systems and be knowledgeable in Emerson’s DeltaV DCS
Demonstrated ability to lead and manage small projects and work effectively as a team player
Experience supporting information interfaces, data conversion and network infrastructure
Working knowledge of pharmaceutical/biotech processes
Working knowledge of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards
Working knowledge of EHSS requirements
Team player who can work with a diverse group of people
Able to work independently
Proactive and willing to take on challenges
Define, measure and improve system performance based on tangible metrics
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