Responsibilities
- Provide solutions to a variety of technical problems of moderate scope and complexity.
- Evaluate, select, and apply standard engineering techniques and procedures under general supervision.
- Assistance given for unusual problems.
- Perform assignments that have clear and specific objectives and require investigation of limited number of variables.
- Initiate and complete routine technical tasks.
- Function as a technical expert to equipment or systems regarding troubleshooting operations.
- Frequently become actively involved in daily operations when required to meet schedules or to resolve complex problems.
- Routinely monitor manufacturing processes for performance indicators and operations.
- Suggest problem resolution and provide troubleshooting guidance.
- Apply engineering principles and statistical analysis, including design of experiments, to solve processing issues and evaluate opportunities for process improvements.
- Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for processes and/or 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 per business needs.
Requirements
- High school diploma / GED and 8 years of Engineering or Operations experience; OR
- Associate’s degree and 6 years of Engineering or Operations experience; OR
- Bachelor’s degree and 2 years of Engineering or Operations experience; OR
- Master's degree.
Nice to Have
- 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 biopharmaceutical manufacturing processes.
- Experience in 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 cGMP requirements
- Experience related to upstream and/or downstream biologics process development technology transfer, scale-up and ongoing manufacturing of biologics (cGMP). This includes technical support for nonconformance investigations and other commercial support activities
- Experience in working with design and optimization of pharmaceutical processing unit operations including cell expansion, harvest, clarification, Protein A, IEX, SEC, TFF, UFDF, and sterile filtration among others for a variety of biological molecules
- Experience in the analysis of data generated from a variety of analytical techniques
- Regulatory knowledge and interactions
- Project management skills
- Strong oral and verbal communication and presentation skills
- Fluency in foreign languages preferred
Benefits
- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- 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, including remote and hybrid work arrangements, where possible
Additional Information
- Domestic and International Travel: up to 15%
- Support non-standard shift organization and extended hours, as per business needs
- Application deadline: Amgen does not have an application deadline for this position; will continue accepting applications until sufficient number or candidate is selected
- Accommodation available for individuals with disabilities during application or interview process
- Equal Opportunity employer: considers all qualified applicants 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
