POSITION SUMMARY:

Reporting to the Manager of Facilities, the Lead Process Equipment Maintenance technician will support Aseptic Fill Finish manufacturing facilities by maintaining production equipment. This position will be the first responder and triage production equipment issues and support the production floor. This position also includes paid rotation in the on-call duties.

PRINCIPAL DUTIES:

• Responsible for process equipment maintenance and troubleshooting for autoclaves, fill lines, washers, ovens, lyophilizers, HVAC equipment etc.
• Coordinates and executes Work order & PM execution
• Performs and manages equipment maintenance as Subject Matter Expert
• Executes and coordinates Shutdown activities as Subject Matter Expert
• Executes process equipment precheck
• Participates in APS intervention
• Completes and/or supports GMP documentation including investigations, CAPA, and Change Controls
• Performs Site project support
• On call duties for production

QUALIFICATIONS AND EXPERIENCE:

• Able to clearly document work and communicate through written word.
• Able to utilize computer-based systems and follow cGDP.
• Able to troubleshoot and repair complex equipment, systems and controls.
• Craftsman level hands on skills with mechanical, electrical, and pneumatics in GMP environments. 
• Clean room gowning qualification.
• High school graduate with higher level technical training.
• Education and technician experience with 8+ years’ in a comparable position.