Process Development Engineer

Career Category

Job Description

Process Development Engineer

Amgen Singapore Manufacturing

HOW MIGHT YOU DEFY IMAGINATION

Amgen is one of the worlds 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 Process Development Engineer in Amgen Singapore Manufacturing.

Live

What you will do

Responsibilities

• Applies expertise in the successful coordination of multiple complex non-routine activities including tech transfer process qualification process performance monitoring floor support troubleshooting of unit operations.
• Support/lead complicated investigations providing concise communications to teams and leadership
• Compile and analyze process data using tools such as excel JMP SIMCA to inform future decision-making and take predictive action
• Author technical protocols technical assessments and product impact assessments
• Verify data in technical reports spreadsheets and regulatory filings
• Utilize strong written and verbal communication skills in technical writing and presentations

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.

Win

What we expect of you

Basic Qualifications

• Masters degree OR
• Bachelors degree and 2 years of directly related experience OR
• Associates degree and/or 4 years of directly related experience OR
• High school diploma / GED and 6 years of directly related experience
• 3 years of relevant work experience in the commercial manufacturing environment within the biotechnology or pharmaceutical industries
• At least 2 years experience with regulated environments (i.e. cGMP) required
• In depth cell culture process knowledge including single-use technologies and harvest technologies
• Experience in providing floor support troubleshooting unit operations and resolving and documenting investigations to support cGMP production
• Possess basic understanding of regulatory and cGMP requirements
• Able to apply engineering principles and advanced statistical analysis in-order to solve processing issues and evaluate opportunities for process improvements
• Able to escalate relevant issues to project lead and line management
• Independently motivated but also work well in team environment
• Strong communication skills (technical writing and verbal communication/presentation)
• Problem solving skills requiring the application of strong scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach

Thrive

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

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.

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.

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.