Support the manufacturing operations team to optimize overall equipment efficiency.
Support the procurement of new systems, oversee FATs, SATs and Qualification of these new systems, layout configuration for new clients, and PFD development and equipment readiness for tech transfers.
Execute process equipment improvement projects stemming from process changes/optimizations, CAPAs, and new capacity demands including compliance item.
Drive continuous improvement and operational excellence culture through self-detecting and self-correcting processes and systems and instilling strong ownership and accountability.
Ensure high levels of communication with team, support resources, and management regarding issues and resolutions.
REQUIREMENTS: Bachelor’s degree in Mechanical, Chemical, Biochemical/Biomedical, Electrical, or Automation Engineering, or related field of study plus 1 year of experience in manufacturing engineering or related experience.
Must have experience or knowledge of:
Operation and support of iCELLis, MVP, and incubators;
Design and implementation of single-use components for bioprocessing operations;
Working as part of a cGMP Operations, CQV, Automation, Engineering, or Maintenance team;
Troubleshooting equipment during cGMP operations;
Visio or CAD; and
Technical documentation review and revision.
TRAVEL: Up to 5% domestic and international travel required.