Maintenance & Calibration Manager, CVRM (Holly Springs)

Roche•South San Francisco, CA

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). The Opportunity We're seeking a highly skilled and experienced Maintenance & Calibration Manager who will be accountable for the execution of maintenance and calibration on production assets for the Holly Springs Drug Product manufacturing. The Manager provides technical oversight for equipment maintenance and utility operations, ensuring safety and regulatory compliance. They manage maintenance budgets, procurement, and service contracts while maintaining accountability for all quality and safety documentation. What You'll Do Pre-Startup: During the plant start-up project you will be on the User Team and be accountable for staffing maintenance and calibration teams, supporting the implementation of all global asset management processes and ensuring appropriate criticality, FMEA, and preventive maintenance and calibration programs are in place. In partnership with the Engineering and the start-up project (user) team you will partner and collaborate with our partner organizations (Engineering and MSAT, 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. 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 technical support to staff in the maintenance, calibration, troubleshooting, and repair of equipment. Ensure work is completed in a safe, compliant, and reliable manner. Review purchasing of repair materials and parts and provide oversight for maintenance activities within budgetary adherence responsibility. Administer service contracts ensuring cost, quality, and delivery achieve the best value and manage ongoing relationships with third party vendors. Accountable for accurate and timely closure of Quality and Safety records within scope of Maintenance & Calibration function. Accountable for planning and managing shutdowns in alignment with the production schedule and supply chain requirements. You will drive optimal greenfield facility and operations design towards high manufacturing efficiency and quality in line with product and regulatory requirements. This includes inputs to the creation of master data in SAP S4/HANA our Computerized Calibration / Maintenance Management Software. You will champion self-initiated or assigned parts of the project within the context of project and company objectives, and justify goals towards management. This also includes provision and realization of creative ideas to drive business and project efficiency and may contain connecting manufacturing technology advances and digital transformation aspects. Presents ideas, project goals, progress, risks, and results across departments and to senior management. You understand the bigger picture of the project and the CVRM disease area and how PT contributes to it. Works closely with the overall project team, the wider organisation and interdepartmental staff to meet department and company goals. Effectively partners with and influences stakeholders across the organization without formal authority, and drives technical decisions balancing product, site, and operations views. You will provide leadership for involved project teams and across the broader organization. Provides training materials and training for people joining the organisation. Acts as a coach for colleagues with less experience and helps them develop skills/expertise. You will ensure 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. Fosters a safe and compliant speak up culture. Actively build, support, and promote a culture of continuous improvement and learning from both successes and failures.

Requirements

Bachelor’s degree in Engineering or a related field
5+ years of work experience in a regulated manufacturing industry with experience in facilities, maintenance, and/or calibration
2+ 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 collaborators, regulatory agencies, and vendors inside and outside the company including coordination across organizational lines, including 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. Is able to coach others
Ability to work in an international/global environment
Domestic and international travel required
Travel up to 20% after full relocation
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

Responsibilities

Accountable for staffing maintenance and calibration teams
Supporting the implementation of all global asset management processes and ensuring appropriate criticality, FMEA, and preventive maintenance and calibration programs are in place
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
Provide technical support to staff in the maintenance, calibration, troubleshooting, and repair of equipment
Review purchasing of repair materials and parts and provide oversight for maintenance activities within budgetary adherence responsibility
Administer service contracts ensuring cost, quality, and delivery achieve the best value and manage ongoing relationships with third party vendors
Accountable for accurate and timely closure of Quality and Safety records within scope of Maintenance & Calibration function
Accountable for planning and managing shutdowns in alignment with the production schedule and supply chain requirements
Drive optimal greenfield facility and operations design towards high manufacturing efficiency and quality in line with product and regulatory requirements
Champion self-initiated or assigned parts of the project within the context of project and company objectives, and justify goals towards management
Presents ideas, project goals, progress, risks, and results across departments and to senior management
Effectively partners with and influences stakeholders across the organization without formal authority, and drives technical decisions balancing product, site, and operations views
Provide leadership for involved project teams and across the broader organization
Provide training materials and training for people joining the organisation
Acts as a coach for colleagues with less experience and helps them develop skills/expertise
Ensure 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
Fosters a safe and compliant speak up culture
Actively build, support, and promote a culture of continuous improvement and learning from both successes and failures