Job Description
Background: The client is a growing pharmaceutical company looking for a Senior engineer that has strong experience with assembly.
Project: We are seeking a Senior Assembly Engineer to support the startup and operationalization of a high-volume auto-injector and pen assembly operation. This individual will serve as the subject matter expert (SME) for combo product assembly manufacturing and play a critical role in transitioning new production lines from design through Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), commissioning, qualification, and commercial operations. Key responsibilities include collaborating with equipment suppliers such as Harro Höfliger and Körber, developing and implementing operational procedures, establishing maintenance and training programs, authoring standard operating procedures (SOPs), and ensuring successful line readiness through Performance Qualification (PQ). The ideal candidate will have extensive experience in auto-injector and/or pen assembly manufacturing, a proven track record of standing up new assembly facilities or production lines, and deep expertise in FAT, SAT, commissioning, and qualification activities. A strong background in Manufacturing Science and Technology (MSAT) or manufacturing engineering is essential, along with experience supporting high-volume commercial manufacturing operations and scaling processes from vendor handoff through sustained production.
Required Skills:
- Assembly
- Manufacturing
Project: We are seeking a Senior Assembly Engineer to support the startup and operationalization of a high-volume auto-injector and pen assembly operation. This individual will serve as the subject matter expert (SME) for combo product assembly manufacturing and play a critical role in transitioning new production lines from design through Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), commissioning, qualification, and commercial operations. Key responsibilities include collaborating with equipment suppliers such as Harro Höfliger and Körber, developing and implementing operational procedures, establishing maintenance and training programs, authoring standard operating procedures (SOPs), and ensuring successful line readiness through Performance Qualification (PQ). The ideal candidate will have extensive experience in auto-injector and/or pen assembly manufacturing, a proven track record of standing up new assembly facilities or production lines, and deep expertise in FAT, SAT, commissioning, and qualification activities. A strong background in Manufacturing Science and Technology (MSAT) or manufacturing engineering is essential, along with experience supporting high-volume commercial manufacturing operations and scaling processes from vendor handoff through sustained production.
Required Skills:
- Assembly
- Manufacturing
Required Skills
auto-injector and pen assembly operation