Lead Maintenance Specialist, Pharma: Compounding & Filling

Genentech, Inc.; Holly Springs (NC); On-site; USD 81,000 - 151,000; Full time

Job summary

Genentech in Holly Springs, NC seeks a Maintenance Specialist with direct pharmaceutical compounding and filling equipment experience to lead troubleshooting and issue resolution, coach Facilities personnel, and serve as owner on projects. During pre-startup you will establish the site maintenance program and support FATs, with flexibility to assist other assets.

Post-startup you will perform GMP maintenance, detailed documentation, training, spare parts input, and SAP master data.

Qualifications

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• You have a High School diploma or equivalent with 7+ years of related work experience in an industrial / manufacturing setting with demonstrated strong mechanical aptitude. An A.A., A.S., A.A.S., or Trade School Certificate is preferred with 5+ years of related work experience. Specifically, experience with maintaining high performance pharmaceutical compounding and filling lines.
• 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 cGMP's, Health Authority regulations, and Quality Systems.
• Strong interpersonal, communication (written and verbal), project management, and time management skills

Responsibilities

• 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 perform 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 support Quality Record management through gathering information and providing SME input. Proficient in Quality Management System(s).
• You will provide inputs to master data needed to support the maintenance program in SAP S4/HANA.
• You will need to understand controlled, classified environments, aseptic processing principles, and maintain associated qualifications for access.
• You will read and understand P & lDs, work from Standard Operating Procedures (SOPs) and leverage basic computer skills using word processors, spreadsheets, databases, and email.

Skills

Mechanical aptitude

AI and digital tools

cGMP familiarity

Project management

Interpersonal communication

Time management

Problem solving

Education

High School diploma

A.A./A.S./A.A.S. or Trade School Certificate

Tools

SAP S4/HANA

Job description

Genentech in Holly Springs, NC seeks a Maintenance Specialist with direct pharmaceutical compounding and filling equipment experience to lead troubleshooting and issue resolution, coach Facilities personnel, and serve as owner on projects. During pre-startup you will establish the site maintenance program and support FATs, with flexibility to assist other assets.

Post-startup you will perform GMP maintenance, detailed documentation, training, spare parts input, and SAP master data.