Senior Engineer (NPI & Glam)

Career Category

Job Description

Join Amgen's Mission to Serve Patients

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.

Senior Engineer I - Process Engineering (New Product & Technologies/ GLAM/ Site Projects)

What you will do

Reporting to the Senior Manager of Engineering, this Senior Engineer position is primarily responsible for leading equipment readiness for New Product and Technologies Introduction (NPI), GLAM and Site Projects in ASM1 and ASM2. This role will serve as a technical project lead for the Biotechnology/ API Manufacturing facility in ASM for the Process Engineering team in the Facilities & Engineering department.

This role will assume the system owner role and lead a team of system owners, taking ownership of process equipment readiness in ASM1 and ASM2. It will be the domain expert (SME) to ensure that the equipment operates, function and performs as intended and is maintained in a validated state. The role includes the supervision and development of system owners and subject matter experts for process equipment and instrumentation, tasked with managing, planning, designing and implementation of changes, commissioning and qualification activities such as protocol/report review and approval, FAT, SAT, PSSR, automation checkouts and IOQ.

This role requires highly cross functional interactions with key site functions to ensure success in equipment readiness for NPI, GLAM and Site Projects in ASM1 and ASM2. 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. 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

• Lead equipment readiness initiatives for NPI, GLAM and Site Projects in ASM1 and ASM2.
• Lead F&E to participate in technical transfer activities and cross-functional meetings as Engineering Technical Lead or Subject matter experts for process equipment for ASM1 and ASM2.
• 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.
• Perform assessments for equipment during new product introduction, change controls and other qualifications activities to ensure equipment are in its validated state.
• Subject matter expert for process equipment performance and operation to ensure safety, compliance and sustained operation
• Build system and capabilities to drive improvements to equipment reliability and maintenance optimization
• Effectively communicate and collaborate with cross function stakeholders to address operational challenges and concerns to ensure sustained operation and minimal interruptions to operational readiness activities.
• 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

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 efficiency 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.

Design & Project Engineering:

• Represent Process Engineering System Owner team and lead equipment readiness initiatives for NPI, GLAM and Site Projects for ASM 1 and ASM2 Process and Process Support Equipment
• Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.
• 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 commissioning and qualification activities such as protocol/report review and approval, FAT, SAT, PSSR, automation checkouts, IQ, OQ, PQ and asset/preventive maintenance/spare parts creation for new process equipment.
• Work independently with research, manufacturing, process development, utilities, maintenance, reliability, facilities, quality assurance and validation departments in developing requirements, design and recommendations for large and/or highly complex system/facility modifications.
• 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 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.

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.

What we expect of you

• Doctorate degree OR
• Master’s degree in Engineering, or related discipline and 2 years of directly related experience OR
• Bachelor’s degree in Engineering, or related discipline and 4 years of directly related experience OR
• Diploma in Engineering, or related discipline and 8 years of directly related experience
• Able to work independently with minimal or no supervision.
• Experience in managing various stakeholders’ expectations related to process equipment in biopharmaceutical/ API as required.
• 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, inoculation, bioreactors, harvest, single use technologies or API processes and critical utilities.
• Experience in validation processes such as generation/execution of Installation/Operation/Performance qualification documentation.
• Knowledge in Automation systems and processes such as 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 require 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 and 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 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.

Apply now and help transform the lives of patients while transforming your career.

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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.