Process Development Engineer

**Process Development Engineer**

**Amgen Singapore Manufacturing**

**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) are the fastest growing region in Amgen. Now we are hiring a Process Development Engineer in **Amgen Singapore Manufacturing**.

**Process Development Engineer**:
**Live**:
**What you will do**

The PD Engineer will provide scientific and technical leadership within the Process Development group at Amgen’s Next Generation Biologics Manufacturing Facility in Singapore. This is one of the most advanced biotech manufacturing facilities in the world: employing the latest technologies for single use processing, connected processing, and real-time process analytical technologies.

**Responsibilities**:

- Process expert with engineering background and experience in commercial production of mammalian cell derived proteins.
- Applies expertise in the successful coordination of multiple, complex, non-routine activities including facility start up, process qualification through to regulatory approval, process performance monitoring, floor support, troubleshooting of unit operations and technology transfer of new processes.
- Must have strong knowledge and understanding of cell culture and/or protein purification processes.
- Must have good understanding of process characterization and process scale up to resolve technical issues observed during transfer / manufacturing at large scale.
- Integrating trends, data and information into plans, deliverables and recommendations
- 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.

**Win**:
**What we expect of you**:
**Qualifications**:

- Master’s degree OR
- Bachelor’s degree and 2 years of directly related experience OR
Associate’s degree and/or 6 years of directly related experience OR
- High school diploma / GED and 8 years of directly related experience
- 5 + years of relevant work experience in the commercial manufacturing environment within the biotechnology or pharmaceutical industries
- At least 3 years’ experience with regulated environments (i.e., cGMP, OSHA, EPA) required
- In depth purification and cell culture process knowledge, including disposables technologies and harvest technologies
- Knowledge of protein chemistry related to commercial monoclonal antibody production
- Experience in providing floor support, troubleshooting unit operations, and resolving and documenting investigations to support cGMP production
- Comprehensive understanding of commissioning, qualification and verification protocol execution requirements
- Comprehensive experience in process characterization and process monitoring programs
- Strong communication skills (technical writing and verbal communication/presentation)
- Familiarity with documentation in a highly regulated environment
- Interacts effectively with variety of communication and working styles
- Ability to independently determine when additional resources are required to solve problems
- Demonstrated skills in the following areas:

- Basic project management
- Commissioning and Qualification
- Scheduling
- Collaboration
- Completion and follow-up
- Ability to provide solutions to a large variety of technical problems

**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

**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.