Senior Project Engineer, Biotech Equipment
Danaher
- Marlborough, MA
- Permanent
- Full-time
- Review and comment user requirements (URS) with customers together with sales or within projects.
- Define overall design approach on multiple customer projects and ensure regulatory requirements are fulfilled on all projects.
- Represent Cytiva in technical discussions with customers during a project and resolve technical questions with customers, suppliers, or internal personnel.
- Coordinate the overall system level detailed design activities across different engineering disciplines.
- Generate and/or approve design outputs, lead technical design reviews, engineering verification activities, and ensure resolution of any issues during manufacturing.
- BSc / MSc in Automation, Electrical, Mechanical or Process / Chemical engineering.
- Minimum of 10 years of engineering experience working on projects delivering technically complex (mechanical, electrical, software) process equipment.
- Customer-focused mentality, highly organized, comfortable with frequent change and with capability to complete multiple tasks / projects on time.
- Ability to drive a concurrent, risk-based engineering culture for project on-time delivery with high quality.
- Experience in qualification activities for process equipment (FAT/SAT/IQOQ).
- Biotech industry and bioprocessing equipment.
- Working knowledge of quality systems such as ISO 9001, ISO 13485, cGMP.