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

Genentech•Holly Springs, NC

8d•$81,400 - $151,200

About The Position

Genentech is hiring a Principal Maintenance Specialist with pharmaceutical compounding and filling equipment experience to support its new CVRM manufacturing facility in Holly Springs, North Carolina. The facility is a $2 billion greenfield project planned to launch in 2028, using advanced automation, robotics, digital tools, and real-time data analytics to manufacture medicines for cardiovascular, renal, and metabolic conditions. 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) and requires collaboration with Engineering and MSAT, Quality, Supply Chain, Technical Development, Regulatory, CMO, and Strategy. Work will initially combine remote and onsite activity, transitioning to full-time onsite work once buildings are complete and equipment is delivered. Project-phase travel of up to 30% is expected. After startup, the specialist will execute maintenance in the field on GMP assets, including preventive maintenance, repairs, and troubleshooting. The role provides technical leadership through complex issue resolution, staff training and mentorship, and project ownership or functional representation. It also supports quality records, spare-parts and bill-of-material improvements, SAP S4/HANA maintenance master data, and PLC and automation troubleshooting. Work must follow applicable SOPs, cGMP requirements, Good Documentation Practices, and safety standards. The specialist must understand controlled and classified environments and aseptic processing principles, and maintain qualifications needed to access those environments. The position has a defined shift, but working hours and schedules may need to flex according to project phase and commercial demand. Overtime and on-call work, including emergency coverage, may be required. The work can involve cleanroom gowning, exposure to hazardous materials, chemicals, and equipment under company safety procedures, lifting up to 35 pounds, navigating stairs, ladders, or scaffolding, transporting equipment, and extended periods standing and away from a desk. Relocation benefits are not available.

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.
Experience maintaining high-performance pharmaceutical compounding and filling lines.
Ability to organize and solve complex, unique, or unprecedented problems using ingenuity and innovation.
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.
Read and understand P&IDs and work from standard operating procedures.
Basic computer skills using word processors, spreadsheets, databases, and email.
Flexibility to work overtime and adjust the working schedule, including flexible hours and on-call work as needed.
Ability to work in cleanroom environments with required gowning and near hazardous materials, chemicals, and equipment while following safety procedures.
Ability to lift up to 35 pounds, navigate stairs, ladders, or scaffolding, transport equipment, and work extended hours standing and away from a desk.

Nice To Haves

A.A., A.S., A.A.S., or trade school certificate, with 5 or more years of related work experience, as an alternative to the high school diploma route requiring 7 or more years.

Responsibilities

Establish the site maintenance program for compounding and filling equipment during plant startup, including procedures and training.
Support factory acceptance tests for compounding and filling equipment.
Support other Holly Springs assets as needed and collaborate with partner organizations including Engineering and MSAT, Quality, Supply Chain, Technical Development, Regulatory, CMO, and Strategy.
Perform planned preventive maintenance, repairs, and troubleshooting on GMP process and utility equipment.
Lead troubleshooting and issue resolution for complex mechanical challenges, including supporting PLC and automation troubleshooting.
Document work promptly and in detail in electronic systems such as SAP and in paper-based systems, following Good Documentation Practices.
Create and facilitate continuing education, training, coaching, and mentorship for maintenance staff.
Identify spare-parts needs and improve bills of material to improve service delivery and reduce equipment downtime.
Support quality record management by gathering information and providing subject-matter expertise.
Provide inputs to SAP S4/HANA master data needed to support the maintenance program.
Follow applicable SOPs, cGMP requirements, and federal, state, local, and company safety standards.
Maintain qualifications for access to controlled and classified environments and work in accordance with aseptic processing principles.
Serve as an owner or functional representative on projects.