Career Category
Engineering
Job Description
Engineer I (Process Engineering)
Amgen Singapore Manufacturing
HOW MIGHT YOU DEFY IMAGINATION?
Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring an Engineer in Amgen Singapore Manufacturing.
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What you will do
Reporting to the Senior Engineer/ Team Lead, this Process Engineer position is primarily responsible for providing operation and New Product Introduction (NPI) support for multiple biologics products and process equipment.
This role will serve as a system owner for the Biotechnology Manufacturing facility in ASM for the Process Engineering team in the Facilities & Engineering department, which collaborates with Engineering Support and Maintenance team, to deliver uninterrupted plant operations. This function operates in conjunction with the manufacturing team to ensure the appropriate and timely completion of cGMP maintenance activities with minimum disruption to manufacturing. The scope includes equipment preparation, buffer/media batching, cell culture, purification, drug substance bulk fill, and analytical operations etc.
This role will assume the system owner role, taking ownership of various process equipment that are used for manufacturing process or supporting manufacturing process. It will be the subject matter expert (SME) to ensure that the equipment operates, function and performs as intended and is maintained in a validated state. Scope of work includes managing, planning and implementation of changes, driving deviation investigations, resolving equipment related process interruptions and development of equipment maintenance program.
This role requires highly cross functional interactions with key site functions to ensure success in production and release performance. Individual must be able to effectively communicate and collaborate closely with the team members and various SME to ensure equipment are operational to sustain daily operations, resolve operation challenges and implement effective measures to address the challenges to ensure without compromising on safety and compliance. It offers a broad exposure to all key aspects of GMP manufacturing as well as tactical and strategic teamwork within the extended worldwide engineering network. In addition, it will also provide advance technical support to ensure the readiness of the equipment/ facility for successful introduction of new products in ASM. The role will be a liaison between corporate engineering and site operations in the design and implementation of new equipment and/or equipment modifications.
Main Responsibilities:
Daily Operations
- Present equipment qualification and equipment related investigations and quality management system records in all site regulatory inspections
- 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.
- Accountable for deviation/change control associated to process equipment performance.
- Provide technical expertise in site selection assessment to identify equipment/facility gaps, select new equipment, assess layout/utilities capacity and partner project managers to develop project cost and schedule.
- Support equipment readiness initiatives for New Product Introduction or Product Campaign Changeover
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 advance 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.
- Perform periodic review and maintain process equipment in validated state.
- Work independently with project managers to complete engineering projects of various scales within schedule, budget, and quality constraints.
- Support commissioning and qualification activities including FAT, SAT, automation checkouts, IQ, OQ, PQ, and asset/preventive maintenance/spare parts creation for new process equipment.
- Participate in the system walk-down, ensure the closure of punch items and support the takeover of the system from the project team.
Design & Project Engineering:
- Work closely with project managers to introduce new equipment including development of business case, project charter, user requirement specifications, quality risk assessments, conceptual design, preliminary design, design specifications and detail design.
- Participate in design review and setup up of new asset and associated maintenance plan/spares in Maximo.
- Participate in commissioning and qualification experience activities such as protocol/report review and approval, FAT, SAT, PSSR, automation checkouts and IOQ.
- Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility modifications.
- Work with project managers to complete design and engineering projects within schedule and budget constraints.
- Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
Organization Leadership
- 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.
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.
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What we expect of you
Basic Qualifications
- 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 con