Senior Engineer I - Process Engineering

Senior Engineer I – Process Engineering (Biologics)

Amgen Singapore Manufacturing, Singapore

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 a Senior Engineer I – Process Engineering (Biologics) in Amgen Singapore Manufacturing.

What You Will Do

Reporting to the Senior Manager of Engineering, this Senior 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 technical lead 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 accurate 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.

This role will assume the system owner role and lead a team of system owners, taking ownership of various process equipment that are used for manufacturing process or supporting manufacturing process. It will be the domain expert (SME) to ensure that the equipment operates, functions and performs as intended and is maintained in a validated state. The role includes the supervision and development of system owners and domain experts for process equipment and instrumentation, tasked with managing, planning and implementation of changes, driving deviation investigations, resolving equipment related process interruptions and development of equipment maintenance program.

This role requires highly multi-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/leadership 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:

• Oversee direct production interruption investigation and serve as critical issue point for resolving equipment process related issues.
• Build system and capabilities to drive improvements to equipment reliability and maintenance optimization.
• Present equipment qualification and equipment related investigations and quality management system records in all site regulatory inspections.
• Coach, mentor and/or cross train staff within core technical areas. Drive forward employee engagement activities to differentiate site/company as a great place to work.
• Support NPI and Site projects as Engineering Technical Lead or Domain experts for process equipment.
• Subject matter expert for process equipment performance and operation to ensure safety, compliance and sustained operation.
• Effectively communicate and collaborate with cross function team members 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 multi-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.
• Lead F&E to participate in technical transfer activities and multi-functional meetings.
• 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 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, budget and quality constraints.
• Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.

Organization Leadership:

• Responsible for management and oversight of team of system owners/ Subject matter experts.
• 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.

Qualifications

What we expect of you:

• Doctorate degree in Engineering OR
• Master’s degree in Engineering and 2 years of directly related experience in a pharmaceutical manufacturing site OR
• Bachelor’s degree in Engineering and 4 years of directly related experience in a pharmaceutical manufacturing site OR
• Diploma and 8 years of directly related experience.
• 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 chromatography, buffer / media tanks, viral filtration, tangential flow filtration is preferred. Process knowledge on inoculation, bioreactors, harvest, single use technologies and critical utilities will also be considered.
• Experience in validation processes such as generation/execution of Installation/Operation/Performance qualification documentation.
• Knowledge in Automation systems and processes such as RD’s, Delta-V, BMS, ladder logic and PLC.
• 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.
• Flexibility to work off-hours.
• Knowledge of Total Productive Maintenance, Reliability Centered Maintenance concepts is an added advantage.

Your selection for this role will be subject to fulfilling the medical requirements of this job scope. If so, you will be informed of the medical check(s) that you may need to undergo. All medical related expenses incurred from this medical check shall be borne by the company.

What You Can Expect Of Us

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• 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.

Apply now for a career that defies imagination. In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.