Senior GMP Maintenance Specialist - Pharma Equipment

Roche; South San Francisco (CA); Hybrid; USD 81,000 - 151,000; Full time

Benefits offered by this job

Discretionary annual bonus

Job summary

Genentech, a Roche subsidiary, is seeking a Maintenance Specialist for its Holly Springs, NC site. The role focuses on leading troubleshooting for complex mechanical challenges on pharmaceutical compounding and filling lines, mentoring facilities staff, and supporting process equipment maintenance.

Initial work involves a mix of remote and on-site duties during startup, with travel up to 30%. The role emphasizes adherence to cGMP, SOPs, and safety standards while supporting QA records and master

Qualifications

• 7+ years of related work experience in an industrial/manufacturing setting with strong mechanical aptitude.
• A.A., A.S., A.A.S., or trade certificate preferred with 5+ years of related work experience.
• Familiarity with cGMPs, Health Authority regulations, and Quality Systems.
• Proficient in using AI and other digital tools to solve complex challenges.

Responsibilities

• Lead field maintenance on GMP assets including planned preventive maintenance and repairs.
• Troubleshoot PLC/automation issues and support root cause analysis.
• Document maintenance activities following Good Documentation Practices (electronic and paper).
• Develop and deliver training for maintenance staff to improve technical skills.
• Assist with spare parts identification and BOM improvements to reduce downtime.
• Support Quality Records management and provide SME input in SAP S/4HANA master data.
• Understand aseptic processing environments and associated qualifications.
• Read P&IDs and operate SOPs using basic computer tools.

Skills

Mechanical aptitude

AI tools

Project management

Communication skills

Education

High School diploma or equivalent

A.A./A.S./A.A.S. or Trade School Certificate

Job description

Genentech, a Roche subsidiary, is seeking a Maintenance Specialist for its Holly Springs, NC site. The role focuses on leading troubleshooting for complex mechanical challenges on pharmaceutical compounding and filling lines, mentoring facilities staff, and supporting process equipment maintenance.

Initial work involves a mix of remote and on-site duties during startup, with travel up to 30%. The role emphasizes adherence to cGMP, SOPs, and safety standards while supporting QA records and master