Engineer
In this vital role you will be responsible for the technology transfer and commercial support of biologics drug substance processes across the network, including both the Amgen manufacturing network and/or Contract Manufacturing Organizations. You will work as a member of a team of engineers and scientists, employing engineering principles to implement manufacturing processes in a cGMP environment.
Responsibilities
- Provide solutions to moderate scope technical problems to enable technology transfer of clinical and commercial molecules.
- Evaluate, select and apply standard engineering techniques and procedures under general supervision, providing assistance for unusual problems.
- Perform assignments with clear objectives, investigating a limited number of variables.
- Initiate and complete routine technical tasks associated with technology transfer.
- Monitor manufacturing processes for performance indicators and operations, suggest problem resolution and provide troubleshooting mentorship.
- Apply engineering principles and statistical analysis, including design of experiments, to address processing issues and evaluate opportunities for process improvements.
- Collaborate with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments to develop requirements and recommendations for processes and system modifications.
- Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints.
- Work with consultants, architects and engineering firms on development of standard design documents.
- Communicate and collaborate with technical and management staff within manufacturing, process development, and quality departments.
- Support non-standard shift organization and extended hours as required by business needs.
- Travel up to 15% (primarily domestic, possibly international).
Qualifications
Basic Qualifications
- Master’s degree; or
- Bachelor’s degree and 2 years of engineering or operations experience; or
- Associate’s degree and 6 years of engineering or operations experience; or
- High school diploma / GED and 8 years of engineering or operations experience.
Preferred Qualifications
- Master’s Degree in Chemical or Biochemical Engineering.
- Education background in Chemical Engineering, Bioengineering or Biotechnology.
- 2+ years of experience in a Process Development/Process Engineering environment, with specific experience in the implementation and support of downstream/purification of commercial cGMP manufacturing facilities.
- Experience in biologics process scale‑up and technology transfer from laboratory to pilot and/or manufacturing scale.
- Experience working with commercial manufacture of biologics using single‑use technology.
- Basic understanding of cGMP requirements.
- Experience related to downstream biologics process development technology transfer, scale‑up and ongoing manufacturing of biologics (cGMP), including technical support for nonconformance investigations and other commercial support activities.
- Experience in design and optimization of downstream processing unit operations including harvest, clarification, Protein A, IEX, SEC, TFF, UFDF, and sterile filtration for a variety of biological molecules.
- Experience in the analysis of data generated from a variety of analytical techniques, troubleshooting, and problem‑solving.
- Regulatory knowledge and interactions.
- Project management skills.
- Strong oral and verbal communication and presentation skills.
Benefits
- A comprehensive employee benefits package, including retirement and savings plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
- A discretionary annual bonus program, or for field sales representatives a sales‑based incentive plan.
- Stock‑based long‑term incentives.
- Award‑winning time‑off plans.
- Flexible work models where possible.
Equal Opportunity Employment
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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