Maintenance & Calibration Senior Manager CVRM (Holly Springs)

Roche • South San Francisco, CA

1d • Onsite

About The Position

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). We're seeking a highly skilled and experienced Maintenance & Calibration Senior Manager who will be accountable for the execution of maintenance and calibration on production assets for the Holly Springs Drug Product manufacturing. The Senior Manager provides technical oversight for equipment maintenance and calibration operations, ensuring safety and regulatory compliance. They manage maintenance budgets, procurement, and service contracts while maintaining accountability for all quality and safety documentation.

Requirements

• Bachelor’s degree in Engineering or a related field.
• 10+ years of work experience in a regulated manufacturing industry with experience in facilities, maintenance, and/or calibration.
• 4+ years of people leadership experience.
• Recognized expert / authority in Maintenance & Calibration in support of GMP bio/pharma manufacturing.
• 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.
• Updated knowledge of cGMP’s, Health Authority regulations, and Quality Systems.
• Experience with health agency inspections (FDA, EMA, Health Canada, etc.).
• Experience with collaborators and vendors inside and outside the company including coordination across organizational lines as well as advising and influencing senior management on advanced technical matters.
• Utilizes an established network for technical issues within the company and the industry.
• Strong organizational and interpersonal skills: can get things done in a way that optimizes results, strengthens internal and external relationships, and with consideration of resources.
• Able to coach others.

Responsibilities

• Staffing maintenance and calibration teams.
• Supporting the implementation of all global asset management processes.
• Ensuring appropriate criticality, FMEA, and preventive maintenance and calibration programs are in place.
• Partnering and collaborating with partner organizations (Engineering and MSAT, Manufacturing, Quality, Supply Chain, Technical Development, Regulatory, CMO, Strategy) to provide expertise in project management and technical design, testing, as well as all other activities related to design and start-up a new Drug Product Fill and Finish facility.
• Providing technical support to staff in the maintenance, calibration, troubleshooting, and repair of equipment.
• Ensuring work is completed in a safe, compliant, and reliable manner.
• Managing expense and capital budgets for the Production Maintenance team and providing stewardship/oversight for site maintenance spend.
• Accurate and timely closure of Quality and Safety records within the scope of Maintenance & Calibration function.
• Planning and managing shutdowns in alignment with the production schedule and supply chain requirements for the large volume products.
• Driving optimal greenfield facility and operations design towards high manufacturing efficiency and quality in line with product and regulatory requirements.
• Establishing and maintaining preventive and corrective maintenance programs to maximize equipment availability and to optimize life-cycle costs.
• Supporting the creation of master data in SAP S4/HANA our Computerized Calibration / Maintenance Management Software.
• Championing self-initiated or assigned parts of the project within the context of project and company objectives, and justifying goals towards management.
• Provision and realization of creative ideas to drive business and project efficiency and may contain connecting manufacturing technology advances and digital transformation aspects.
• Presenting ideas, project goals, progress, risks, and results across departments and to senior management.
• Working closely with the overall project team, the wider organization and interdepartmental staff to meet department and company goals.
• Effectively partnering with and influencing stakeholders across the organization without formal authority, and driving technical decisions balancing product, site, and operations views.
• Driving collaboration within site and across network activities, cross-functional planning, and decision making.
• Providing training materials and training for people joining the organization.
• Acting as a coach and mentor for colleagues with less experience and helping them develop skills/expertise.
• Ensuring the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents within one’s functional area.
• Fostering a safe and compliant speak up culture.
• Actively building, supporting, and promoting a culture of continuous improvement and learning from both successes and failures.

Benefits

• Relocation Assistance is available for this role.
• A discretionary annual bonus may be available based on individual and Company performance.
• This position also qualifies for the benefits detailed at the link provided below.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees