Lead Maintenance Specialist - Medical Device Assembly (GMP)

F. Hoffmann-La Roche AG; Holly Springs (NC); Sur place; USD 81 000 - 151 000; Plein temps

Résumé du poste

Genentech, part of Roche, seeks a Maintenance Specialist for Medical Device Assembly Equipment to lead troubleshooting and maintenance on GMP assets at the Holly Springs site. You will coach maintenance staff, support start-up activities, and partner with Engineering, MSAT, Quality, and Supply Chain.

The role requires 7+ years in industrial manufacturing with strong mechanical aptitude; a trade certificate is preferred.

Qualifications

• 7+ years of related work experience in an industrial/manufacturing setting with strong mechanical aptitude.
• An A.A., A.S., A.A.S., or Trade School Certificate is preferred with 5+ years of related work experience, especially maintaining a medical device assembly line.
• Familiarity with cGMPs, Health Authority regulations, and Quality Systems.
• Ability to read P&IDs and work from SOPs; proficient with basic computer tools.

Responsabilités

• Lead in-field maintenance activities on GMP assets, including planned preventive maintenance and repairs.
• Troubleshoot PLC/automation systems and document work per Good Documentation Practices (SAP and paper-based).
• Develop and deliver continuing education for maintenance staff through training and mentorship.
• Identify spare parts and BOM improvements to reduce downtime and improve service delivery.
• Read P&IDs, SOPs, and use SAP S4/HANA for master data inputs.
• Support Quality Record management by gathering information and acting as SME.
• Understand controlled, aseptic environments and related qualifications for access.

Connaissances

Mechanical aptitude

Problem solving

Project management

Digital tools

Communication skills

Formation

High School diploma or equivalent

A.A./A.S./A.A.S./Trade School Certificate preferred

Outils

SAP S4/HANA

Description du poste

Genentech, part of Roche, seeks a Maintenance Specialist for Medical Device Assembly Equipment to lead troubleshooting and maintenance on GMP assets at the Holly Springs site. You will coach maintenance staff, support start-up activities, and partner with Engineering, MSAT, Quality, and Supply Chain.

The role requires 7+ years in industrial manufacturing with strong mechanical aptitude; a trade certificate is preferred.