Sr Engineer ( Single Use Systems Engineering)
Amgen
- Cambridge, MA
- $114,962-139,704 per year
- Permanent
- Full-time
- Evaluate Single Use Systems (SUS) designs to make sure they follow engineering standards, specifications, and industry best practices across Amgen network
- Partner with multi-functional collaborators in Quality, Supply Chain, Materials Sciences, Process Development, and Manufacturing to establish requirements and design standards for new SUS technologies and capabilities
- Provide engineering support to vendor selection and management, issue investigations, root cause analysis, and CAPA implementation for SUS components and assemblies
- Support commissioning and qualification of SUS equipment and systems, ensuring alignment with engineering standards and good engineering practices
- Support operations and maintenance of SUS equipment and systems, providing fixing, reliability analysis, and system optimization
- Conduct and/or oversee engineering studies, experiments, and validations to support the design, development, and qualification of SUS components and assemblies
- Master’s Degree in Engineering, Materials Sciences or Life Sciences
- 5+ years of Engineering or technical experience in an engineering environment, with specific specialized expertise in the design, specification and management of Single Use Components for use in Biotech or related/applicable experience, or in the manufacturing of process components from plastics, polymers and elastomers
- Experience providing process engineering support in biotech/pharmaceutical industry supporting pilot/clinical/commercial manufacturing
- Strong understanding of GMP equipment design and biologics manufacturing requirements
- Ability to manage and deliver results in a highly fluid, multi-functional matrixed environment
- Excellent communications skills, strong facilitation talent, and executive presence to drive multi-functional objectives across Amgen’s international network.
- 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.
- 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 and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possible