Engineer – Process Engineering - API

Career Category

Engineering

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.

Engineer – Process Engineering

What you will do

This role will serve as a process equipment system owner for the Chemical Synthesis API Manufacturing Facility in ASM for the facilities and engineering team.

The role will be a liaison between manufacturing, maintenance, engineering and automation in the troubleshooting and resolution of equipment related issues.  Experience in design, qualification, operation, maintenance and improvement of Chemical Synthesis API process equipment will be required to support day to day manufacturing activities as well as to lead improvement projects. Overall Chemical Synthesis processes knowledge will be required to perform complex troubleshooting activities. This role is crucial for Amgen’s success and it will be a key contributor in the ASM- Chemical Synthesis API Manufacturing Facility. This role will partner with vendors/networks to determine innovative opportunities to improve the site’s reliability, efficiency, agility and differentiation.

Main Responsibilities:

Operational Support

• Subject matter expert for process engineering (including process equipment and process automation) to support manufacturing to ensure safety, compliance and sustained operation.
• Lead and participate in the investigation and troubleshooting of process equipment related issues.
• Identify effective recommendation on corrective actions, preventive actions and improvements.
• Effectively communicate and collaborate with cross function stakeholders to address operational challenges and concerns to ensure sustained operation and minimal interruptions.
• Provide technical expertise in operational continuous improvement projects or initiatives (yield improvements, risk mitigation, capacity expansion etc.), to translate equipment and automation requirement, propose engineering solutions, collaborate with cross-functional team to deliver.

Equipment Design & Qualification - Project Engineering:

• Participate in design review and set up of new asset and associated maintenance plan/spares in Maximo.
• Participate in commissioning and qualification activities such as IOQ protocol/report review and approval, FAT, SAT, PSSR. 
• Work with stakeholders (e.g., manufacturing, process development, quality assurance, validation) to develop requirements and implement equipment / facility modifications.
• Develop technical solutions to problems requiring the regular use of ingenuity and creativity.       

Innovation:

• Continuously improve Business Intelligence capabilities (e.g., ability to extract, manipulate, analyze and trend performance data).
• Benchmark equipment performance (e.g., reliability, productivity) and ident improvement plans.
• Assess predictive technologies for implementation.

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.

What we expect of you

Basic Qualifications

• Master’s degree OR
• Bachelor’s degree 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

​Preferred Qualifications

• Working experience in process engineering team in chemical synthesis API manufacturing.
• Established expertise in at least 2 separate areas of engineering technology such as equipment design/operation/maintenance, automation, process engineering, project management and/or validation.
• Working knowledge of high potency active pharmaceutical ingredient (API) processes involving equipment such as Glass lined reactors, Filter dryer, Isolators and critical utilities such as TCU and Scrubber will be an added advantage.
• 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.
• Foster and maintain relationships with key site stakeholders.
• Good communications skills, both oral and written, including presentation skills.
• 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 identify best business solution.
• Knowledge of Operational Excellence practices such as lean manufacturing and lean maintenance is a plus.

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.

careers.amgen.com

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.

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