Principal Maintenance Specialist, Assembly - CVRM (Holly Springs)

F. Hoffmann-La Roche AG; Holly Springs (NC); Sur place; USD 81 000 - 151 000; Plein temps

Résumé du poste

Genentech, part of Roche, seeks a Maintenance Specialist for Medical Device Assembly Equipment to lead troubleshooting and maintenance on GMP assets at the Holly Springs site. You will coach maintenance staff, support start-up activities, and partner with Engineering, MSAT, Quality, and Supply Chain.

The role requires 7+ years in industrial manufacturing with strong mechanical aptitude; a trade certificate is preferred.

Qualifications

• 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 related work experience, especially maintaining a medical device assembly line.
• Familiarity with cGMPs, Health Authority regulations, and Quality Systems.
• Ability to read P&IDs and work from SOPs; proficient with basic computer tools.

Responsabilités

• Lead in-field maintenance activities on GMP assets, including planned preventive maintenance and repairs.
• Troubleshoot PLC/automation systems and document work per Good Documentation Practices (SAP and paper-based).
• Develop and deliver continuing education for maintenance staff through training and mentorship.
• Identify spare parts and BOM improvements to reduce downtime and improve service delivery.
• Read P&IDs, SOPs, and use SAP S4/HANA for master data inputs.
• Support Quality Record management by gathering information and acting as SME.
• Understand controlled, aseptic environments and related qualifications for access.

Connaissances

Mechanical aptitude

Problem solving

Project management

Digital tools

Communication skills

Formation

High School diploma or equivalent

A.A./A.S./A.A.S./Trade School Certificate preferred

Outils

SAP S4/HANA

Description du poste

Pharma Technical Manufacturing (PTM) is responsible for managing all aspects of end-to-end drug substance and drug product manufacturing and supply. From the raw material to the final medicine, we contribute to deliver Roche’s ground-breaking therapies to more than 120 million patients around the world. We make our medicines at 9 sites around the world and coordinate all aspects of production of Roche medicines in all disease areas and dosage forms.

To ensure readiness for a step-change in the standard of care that Roche delivers in the area of Cardiovascular, Renal and Metabolism (CVRM), PTM will construct a new manufacturing site in the U.S. in Holly Spring, North Carolina. The new site will focus on large volume low cost Drug Product manufacturing (Component Prep & Compounding, Liquid PFS Filling, Automated Inspection, Autoinjector Assembly, Packaging/Finished Products).

The Opportunity

We’re seeking a highly skilled Maintenance Specialist with direct Medical Device Assembly Equipment experience who will be accountable for leading troubleshooting and issue resolution for highly complex mechanical challenges, providing coaching / mentorship / training of other Facilities personnel, and serve as owners or functional representatives on projects. In addition, they are accountable to support the maintenance of process and utility equipment supporting production in Holly Springs.

What You’ll Do

Pre-Startup:

During the plant start-up project you will be on the User Team and be responsible for establishing the site’s maintenance program for Assembly equipment including procedures and training. You will also be responsible for supporting FAT for Device Assembly Equipment. While this role is focused on Assembly, you are expected to be able to flex to support other Holly Springs assets as well. To accomplish this, you will partner and collaborate with our partner organizations (Engineering and MSAT, Quality, Supply Chain, Technical Development, Regulatory, CMO, Strategy).

Initially, you will perform a mix of remote and onsite work (first at the General Planner’s office, later at construction site/plant). You will transition to local full time on-site work once the site buildings are built and equipment 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 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 need to Read and Understand P&lDs, 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. Proficient in Quality Management System(s).
• You will need to understand controlled, classified environments, aseptic processing principles, and maintain associated qualifications for access.

Who You Are

• 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 a medical device assembly line.
• 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

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 35 lbs, navigating stairs/ladders/scaffolding, transporting equipment to the location of instruments, 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 $81,400 - $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.

Link to Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company’s policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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