Principal Maintenance Specialist, Assembly (CVRM)

About the role

Roche's Pharma Technical Manufacturing (PTM) is building a new manufacturing site in Holly Springs, North Carolina, focused on large-volume, low-cost drug product manufacturing (component prep and compounding, liquid PFS filling, automated inspection, autoinjector assembly and packaging). The Principal Maintenance Specialist leads troubleshooting and issue resolution for complex mechanical challenges on medical device assembly equipment, coaches and mentors facilities personnel, and acts as owner or functional representative on projects, while supporting maintenance of process and utility equipment.

Key responsibilities

• Pre-startup: join the User Team to establish the site's maintenance program for Assembly equipment, including procedures and training, and support FAT for device assembly equipment; initially a mix of remote and onsite work, then full-time on-site once buildings and equipment arrive, with travel of up to 30% during the project phase.
• Post-startup: carry out planned preventative maintenance and repairs/troubleshooting on GMP assets, including PLC/automation troubleshooting, in line with SOPs, cGMP and safety standards.
• Document work in detail in electronic (e.g. SAP) and paper systems following Good Documentation Practices.
• Create and run continuing education for maintenance staff through training, coaching and mentorship.
• Help identify spare parts and BOM improvements to reduce downtime.
• Provide inputs to master data in SAP S4/HANA and support Quality Record management.

Required profile

• High school diploma or equivalent with 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 certificate is preferred with 5+ years.
• Experience maintaining a medical device assembly line.
• Familiarity with cGMP, health authority regulations and quality systems.
• Ability to solve complex problems, strong communication, project management and time management skills.
• Proficiency with AI and other digital tools.
• Willingness to work shifts, overtime or on-call, and to work in a clean room with gowning, near hazardous materials, and to lift up to 35 lbs and stand for most of the shift.

Required skills

• Reading and understanding P&Ls and working from SOPs
• Basic computer skills (word processors, spreadsheets, databases, email)
• Proficiency in Quality Management Systems
• Understanding of controlled, classified environments and aseptic processing principles

Salary range for Holly Springs: $81,400 - $151,200, depending on experience and qualifications; a discretionary annual bonus may be available.