Instrumentation Specialist (Calibration)

About the role

Roche/Genentech is building a new $2B drug product manufacturing facility in Holly Springs, North Carolina, focused on cardiovascular, renal and metabolism medicines. It is looking for a highly skilled Calibration Specialist covering fill/finish, package/assembly and utilities, who leads troubleshooting and issue resolution for complex calibration challenges, coaches and mentors other instrumentation personnel and acts as owner or functional representative on projects. The role supports calibration of process, utility and QC lab equipment.

Key responsibilities

• Pre-startup: join the User Team to set up the site's calibration program (procedures and training) and partner with instrumentation and control engineers to establish a metrology program; potentially support FAT for production equipment.
• Transition to full-time on-site work after buildings are built and equipment delivered, with travel of up to 30% during the project phase.
• Post-startup: carry out planned preventative calibration and repairs/troubleshooting of GMP assets, including PLC/automation issues, in line with SOPs, cGMP and safety standards.
• Document work in detail in electronic (e.g. SAP) and paper systems, and create continuing education for calibration staff.
• Help identify spare parts and BOM improvements, and contribute master data to the calibration program in SAP S4/HANA.
• Support Quality Record management and own quality events such as deviations and planned changes.

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 school certificate is preferred, with 5+ years of experience, including maintaining high-performance pharmaceutical packaging lines.
• Familiarity with cGMP, health authority regulations and quality systems.
• Ability to solve complex problems, use AI and digital tools, and work in a clean room environment with gowning; flexibility for overtime and schedule changes.

Required skills

• Read and understand P&L diagrams and work from SOPs.
• Basic computer skills with word processors, spreadsheets, databases and email.
• Proficiency in Quality Management Systems and understanding of controlled, classified environments and aseptic processing principles.

Salary range for Holly Springs: $81,200 - $150,800, depending on experience and qualifications; a discretionary annual bonus may be available.