Engineer (Process Engineering)

• Providing operation and New Product Introduction (NPI) support for multiple biologics products and process equipment
• Assuming system owner role, taking ownership of various process equipment
• Subject matter expert (SME) to ensure equipment operates, functions and performs as intended
• Managing, planning and implementation of changes, driving deviation investigations, resolving equipment related process interruptions
• Developing equipment maintenance program
• Presenting equipment qualification and equipment related investigations in all site regulatory inspections
• Leading and participating in equipment breakdown investigations
• Performing assessment for equipment during new product introduction, change controls and other qualifications activities
• Accountable for deviation/change control associated to process equipment performance
• Providing technical expertise in site selection assessment
• Supporting equipment readiness initiatives for New Product Introduction or Product Campaign Changeover
• Participating in related AMGEN network forums for continuous improvement
• Periodically reviewing and/or improving equipment safety, maintenance strategy, spare parts
• Working independently with project managers to complete engineering projects
• Supporting commissioning and qualification activities including FAT, SAT, automation checkouts, IQ, OQ, PQ
• Participating in system walk-down and ensuring closure of punch items
• Working closely with project managers to introduce new equipment
• Participating in design review and setup of new asset
• Participating in commissioning and qualification experience activities
• Working with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments
• Developing technical solutions to complex problems

• Masters Degree OR Bachelor's Degree and 2 years of directly related experience OR Associate's Degree and 6 years of directly related experience OR High School Diploma / GED and 8 years of directly related experience
• Able to work independently with minimal 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
• Problem solving skills require the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach
• Working knowledge of biopharmaceutical processes such as chromatography, buffer / media tanks, viral filtration, tangential flow filtration, inoculation, bioreactors, harvest, single use technologies and critical utilities is preferred
• Experience in validation processes such as generation/execution of Installation/Operation/Performance qualification documentation is preferred
• Knowledge in Automation systems and processes such as RD's, Delta-V, BMS, ladder logic and PLC is preferred
• Demonstrated project management skills (schedule/cost development, facilitation, collaboration, basic project management, completion and follow-up) and application of concepts will be an advantage
• Flexibility to work off-hours
• Knowledge of Total Productive Maintenance and Reliability Centered Maintenance concepts is an added advantage

Knowledge of Total Productive Maintenance and Reliability Centered Maintenance concepts

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits