Engineer I – Process Engineering (Biologics)

At Amgen, our shared mission to serve patients living with serious illnesses drives everything we do. Every team member plays an important role in helping advance science and deliver medicines that make a meaningful difference for patients around the world.

Amgen fights the world's toughest diseases by harnessing the best of biology and technology. We draw on our scientific expertise to push beyond what is known today and help people live longer, fuller lives.

If you are energized by collaboration, continuous learning, and meaningful work, we invite you to join our team and help make an impact.

Reporting to the Senior Engineer/ Team Lead/ Manager, this Process Engineer position is primarily responsible for providing operation and New Product Introduction (NPI) support for ASM1 Process Equipment. This role will serve as a system owner for an assigned portfolio of process-support equipment 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 covers both upstream and downstream process areas, including cell culture and harvest filtration, as well as viral inactivation, purification and drug substance bulk fill.

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 technical resource or equipment subject matter expert (SME) for assigned systems 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:

• Own the day-to-day engineering support, equipment performance, validated state, maintenance plans and lifecycle actions for an assigned portfolio of ASM1 Process Equipment.
• 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 equipment investigations of moderate complexity, identify root causes, assess technical options, recommend corrective and preventive actions, and drive approved actions to closure. 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 periodic review and maintain process equipment in validated state.
• 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. Act as technical owner for assigned deviations and change controls, ensuring accurate technical assessment, timely execution and closure. Final approval remains with designated Engineering and Quality approvers.
• Own defined equipment-readiness deliverables for NPI and site projects, including qualification support, punch-list closure, maintenance and spare-parts readiness, and system turnover
• Provide technical guidance to Manufacturing, Maintenance, Quality and project teams for assigned equipment and coordinate implementation of agreed technical solutions.

• 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.
• Build system and capabilities to drive improvements to equipment reliability and maintenance optimization
• Periodically review and/or improve equipment safety, maintenance strategy, spare parts, and other continuous improvement opportunities to enhance reliability.

• Support the functional lead in providing ASM1 Process Equipment readiness support for NPI, GLAM and Site Projects for Process-Support Equipment
  • Where appropriate, provide engineering advice to 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.
  • Develop technical solutions to technical problems of moderate complexity requiring analysis and engineering judgment.

• 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 accommodation for additional tasks and responsibilities.

• Able to work independently under general direction and independently manages familiar assignments, escalating novel or high-impact issues.
• 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, 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.

• Master’s degree in Engineering OR
• Bachelor’s degree in Engineering and 2 years of directly related experience OR
• Associate’s degree and/or 4 years of directly related experience OR
• High school diploma / GED and 6 years of directly related experience

As we work to develop medicines for patients, we also invest in our people. Through competitive benefits, development opportunities, and a collaborative culture, we'll support your growth both professionally and personally.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values as we continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity Employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided 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 accommodation.