Principal Maintenance Specialist, Compounding and Filling - CVRM (Holly Springs)

Roche•South San Francisco, CA

11d•$81,400 - $151,200

About The Position

Genentech is seeking a Maintenance Specialist with direct pharmaceutical compounding and filling equipment experience for its Holly Springs, North Carolina facility. The role leads troubleshooting and resolution of complex mechanical challenges, supports maintenance of process and utility equipment, coaches and trains other Facilities personnel, and serves as an owner or functional representative on projects. During pre-startup, the specialist will join the User Team and establish the site maintenance program for compounding and filling equipment, including procedures and training. The role also supports Factory Acceptance Tests (FATs) for this equipment and may flex to support other Holly Springs assets. The specialist collaborates with Engineering and MSAT, Quality, Supply Chain, Technical Development, Regulatory, CMO, and Strategy. Early work will combine remote and onsite duties, progressing from the General Planner’s office to the construction site or plant. Once buildings are constructed and equipment is delivered, the role transitions to full-time local onsite work. Travel of up to 30% is expected during the project phase. After startup, the specialist executes maintenance activities in the field on GMP assets, including preventive maintenance, repairs, troubleshooting, and support for PLC and automation troubleshooting. Work must follow applicable SOPs, cGMP requirements, and federal, state, local, and Genentech safety standards. Responsibilities also include detailed and timely documentation in electronic systems such as SAP and in paper-based systems; continuing education, training, coaching, and mentoring for maintenance staff; identifying spare parts and improving bills of materials (BOMs); contributing subject-matter expertise to Quality Record management; and providing master-data inputs for the SAP S4/HANA maintenance program. The specialist must understand controlled and classified environments and aseptic processing principles, and maintain the qualifications required for access. The role requires reading and understanding P&IDs, following SOPs, and using basic computer tools such as word processors, spreadsheets, databases, and email. The work schedule is defined but may change according to project phase or commercial demand. Flexible hours, overtime, and on-call work—including occasional emergency response—may be required. The work may involve clean-room gowning, exposure to hazardous materials, chemicals, and equipment under company safety procedures, lifting up to 35 pounds, using stairs, ladders, or scaffolding, transporting equipment, and extended periods standing and working away from a desk. Relocation benefits are not available. The expected salary range for the Holly Springs location is $81,400–$151,200; actual pay depends on experience, level, qualifications, location, and other job-related factors. A discretionary annual bonus may be available based on individual and company performance.

Requirements

High school diploma or equivalent and 7 or more years of related work experience in an industrial or manufacturing setting, with demonstrated strong mechanical aptitude; alternatively, an A.A., A.S., A.A.S., or Trade School Certificate and 5 or more years of related work experience is preferred.
Experience maintaining high-performance pharmaceutical compounding and filling lines.
Ability to organize and solve complex, unique, or unprecedented problems using ingenuity and innovation.
Demonstrated courage and drive to achieve optimal business results.
Proficiency using AI and other digital tools to solve complex challenges.
Familiarity with cGMP, Health Authority regulations, and Quality Systems.
Strong interpersonal, written and verbal communication, project management, and time management skills.
Ability to work flexible hours, overtime, and on-call as business needs require.
Ability to work in clean rooms using required gowning, potentially near hazardous materials, chemicals, and equipment.
Ability to lift up to 35 pounds, navigate stairs, ladders, and scaffolding, transport equipment, and work for extended periods standing and away from a desk.
Ability to maintain qualifications for access to controlled and classified environments.

Nice To Haves

An A.A., A.S., A.A.S., or Trade School Certificate, paired with 5 or more years of related work experience.

Responsibilities

Lead troubleshooting and resolution of complex mechanical challenges involving pharmaceutical compounding and filling equipment.
Support maintenance of production process and utility equipment.
Coach, mentor, and train Facilities and maintenance personnel.
Serve as an owner or functional representative on projects.
Establish the site maintenance program for compounding and filling equipment during startup, including procedures and training.
Support Factory Acceptance Tests (FATs) for compounding and filling equipment.
Collaborate with partner organizations including Engineering and MSAT, Quality, Supply Chain, Technical Development, Regulatory, CMO, and Strategy.
Execute field maintenance on GMP assets, including preventive maintenance, repairs, and troubleshooting.
Support troubleshooting of PLC and automation systems.
Follow applicable SOPs, cGMP requirements, and safety standards; complete timely documentation in electronic and paper-based systems.
Create and facilitate continuing education and provide formal and informal training, coaching, and mentorship for maintenance staff.
Identify spare parts and improve bills of materials to enhance service delivery and reduce equipment downtime.
Support Quality Record management by gathering information and providing subject-matter expertise.
Provide master-data inputs to support the SAP S4/HANA maintenance program.
Understand controlled and classified environments and aseptic processing principles, and maintain required access qualifications.
Read and understand P&IDs, work from SOPs, and use basic computer applications.
Flex to support other Holly Springs assets as needed.
Work flexible hours, overtime, or on-call shifts as required by business needs.