The Opportunity

We are seeking a highly skilled and motivated maintenance specialist with direct experience in the operation and maintenance of clean utility and plant utility systems. This individual will be accountable for leading troubleshooting efforts, supporting system start-up, providing coaching and training to other personnel, and serving as owner or functional representatives on projects. In addition, they will be accountable to support maintenance of process equipment and infrastructure throughout the Holly Springs site.

As a PrincipalClean Utilities System Specialist / Senior Clean Utilities System Specialist within Facilities & Engineering, you will own the integrity, reliability, and compliance of the critical lifelines of our manufacturing process. Without your expertise in high-purity systems, our state-of-the-art facility cannot deliver life-saving therapeutics. You are someone who thrives in the ambiguity of a startup environment, values safety above all else, and executes with the uncompromising rigor of a world-class cGMP organization.

What You'll Do

Pre-Startup:

During the plant start-up project, you will serve as a user team representative and be responsible for establishing the sites maintenance program for clean utility systems. This will include development of procedures and training programs, spare part strategy, master data creation, and maintenance plan creation. You will also support FATs and SATs for clean utility equipment and process equipment as needed. While this role is focused on Clean Utilities, you are expected to be able to flex to support other asset management functions of the Holly Springs site. You will provide technical support through all phases of the project, including design review, installation, commissioning, qualification, and system turnover. You will partner and collaborate with other organizations such as Engineering, MSAT, Quality, QC, Supply Chain, and Production to accomplish this.

Initially, you will perform a mix of remote and onsite work (first at our temporary office location, later at the construction site). You will transition to local full time on-site work once the site buildings are built and equipment is delivered. Travel of up to 30% of the time is expected during the project phase.

Post-Startup:

• You will provide in the field execution of maintenance activities on GMP assets. This will include both planned preventative maintenance and repairs / troubleshooting. Supporting troubleshooting of PLC/automation is expected. This will be done while adhering to applicable SOPs, complying with cGMP, and adhering to Federal, State, Local, and Genentech safety standards.

• You will operate, maintain, and repair site utility infrastructure equipment within a cGMP facility, including utilities, electrical, and HVAC systems; not limited to water-for-injection, chilled water, clean steam, heating hot water, cold rooms, cooling towers, fire protection, and control systems supporting 24/7 manufacturing, lab, and warehouse operations.

• You will perform accurate and timely detailed documentation following Good Documentation Practices in electronic (e.g. SAP) and paper based systems.

• You will create and facilitate continuing education for the maintenance staff to increase technical skills through formal and informal training, coaching and mentorship.

• You will provide assistance with identification of spare parts and BOM improvements to improve service delivery and reduce equipment downtime.

• You will need to Read and Understand PlDs, work from Standard Operating Procedures (SOPs) and have basic computer skills using word processors, spreadsheets, databases, and email.

• You will provide inputs to master data needed to support the maintenance program in SAP S4/HANA.

• You will support Quality Record management through gathering information and providing SME support. Proficient in Quality Management System(s).

• You will need to understand controlled, classified environments, aseptic processing principles, and maintain associated qualifications for access.

• You will oversee external service providers supporting equipment, building infrastructure, security, cleaning, waste management, and repairs.

• You will plan and execute improvements, repairs, asset replacements, and safe shutdown and startup activities.

• You will serve as the primary first responder to facility-related alarms.

• You will manage change through established change management systems.

• You will initiate deviations and provide investigation support and root cause analysis.

• You will champion lessons learned, information sharing, and authorship of technical reports.

• You will maintain a state of audit-readiness at all times.

Who You Are

• Senior Level: High School diploma or equivalent with 10+ years of related work experience in an industrial / manufacturing setting with demonstrated strong mechanical aptitude OR An A.A., A.S., A.A.S., or Trade School Certificate is preferred with 8+ years of related work experience.

• Principal Level: High School diploma or equivalent with 14+ years of related work experience in an industrial / manufacturing setting with demonstrated strong mechanical aptitude OR An A.A., A.S., A.A.S., or Trade School Certificate is preferred with 12+ years of related work experience.

• You have an ability to organize and solve complex, unique or unprecedented problems through the regular use of ingenuity and innovation; consistently demonstrating courage and drive to ensure optimal business results.

• You are proficient in using AI and other digital tools to solve complex challenges

• You have familiarity with cGMPs, Health Authority regulations, and Quality Systems.

• Strong interpersonal, communication (written and verbal), project management, technical writing, and time management skills

• You have extensive experience with utility, heating, ventilation, and airconditioning, or electrical systems in regulated environments such as biotechnology, pharmaceuticals, hospitals, universities, government, nuclear facilities, or semiconductor settings.

• You are experienced with Building Management Systems, Computerized Maintenance Management Systems, and predictive maintenance technologies.

• You have a handson background in maintenance operations, engineering support, equipment installation or service, or instrument calibration or programming.

• You have the ability to read and interpret mechanical drawings, electrical schematics, hydraulic and pneumatic diagrams, and piping and instrumentation diagrams.

Work Environment/Safety Considerations:

• This role will have a defined work shift but will require flexible working hours including overtime or on-call (sometimes in an emergency situations) to meet business needs.

• May work in the clean room environment that requires gowning in the form of hospital scrubs, bunny suits, gloves, and steel toe boots.

• Potential to work near hazardous materials, chemicals, and equipment as per company safety procedures and guidelines.

• Active role which includes lifting up to 50 lbs, navigating stairs/ladders/scaffolding, transporting equipment, material movement, and working away from a desk for the majority of working shift.

• Be able to work extensive hours while standing

The expected salary range for this position based on the primary location for this position of Holly Springs, North Carolina $63,500 - $151,200. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

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