Senior Principal MES Engineer (CVRM)

ITOT supports Pharma Technical Manufacturing (PTM), 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 nine 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. ITOT will own and operate Manufacturing Technology stack at the site working with Global IT. 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

A Senior Principal MES Engineer/ Leader is being hired to participate in Greenfield Project execution and then support the facility after going live.

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.

What You'll Do

The Senior Principal MES Engineer will be responsible for providing Manufacturing Execution Systems (Pharmasuite MES) capabilities and experience to the ITOT / MES Group including generating qualification protocols and maintaining the validated state of systems and processes. Initially, participates in Basic Design, Detailed Design and Facility Startup. Eventually focuses on providing long-term support for newly built facilities with respect to the manufacturing execution systems for process, utility and building systems as appropriate. Lead MES impacting projects with large and/or complex scope. Drive strategic initiatives to improve business processes.

• MES System implementation including System architecture components and Recipe Authoring for drug product manufacturing processes in GMP environment

• Co-create MES strategy and roadmap with business partners (Business Process Owner/Manager, Site Stakeholders and Global MES Core Product Owner) in collaboration with IT Partners (Architects, Global Infrastructure, Business Analysts and MES Core Product Manager) plus external vendors.

• Produce and review design specification documents (URS,PRS,FS, DS, etc.).

• Support end-to-end system qualification, including test creation, execution, review and approval.

• Manage personal project activities (design and qualification) following Genentech/Roche business processes to deliver results that are right first time, on-time with schedule requirements and reconciled to the budget.

• Support plant operations to assess discrepant events and changes for automation impact, deliver automation solutions to resolve operational issues, assist in troubleshooting and providing real time on floor support of manufacturing operations, participate in site coordination meetings and attend network meetings.

• Author and then Adhere to site SOPs and work instructions for daily and project deliverables. Drive improvements to business processes.

• Support inspection activities to present automation design and qualification deliverables and strategy (e.g. Qualification Project Plans and Master Plans).

• Adhere to company policies regarding performance management, department time reporting and notification requirements, budget, and expense reporting guidelines.

• MES lead for equipment/software FAT, SAT, field testing and commissioning

• Provide scope, qualification, resource, and budget estimates for MES impacting projects.

• Manage employees/ contractor staff, track project deliverables, and provide status updates to the project team.

• Manage teams (contractor and FTE staff) by setting clear expectations for work delivered and behaviors. Monitor performance and ensure contractual obligations are met. Complete timely review of time sheets and invoices.

• Provide input into network/global business processes and procedures (e.g. GSPs).

• All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).

• Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one's functional area. Fosters a positive safety culture in which no one gets hurt.

• Represent and mitigate MES dependencies as related global systems evolve their business processes and technologies (e.g. SAP upgrade & LIMS replacement).

• Accountable for MES Support team in a 24/7 GMP Manufacturing environment

• Lead teams/ Provide 24/7 on call support for Manufacturing Computerized Systems (GMP)

• Work to identify opportunities to create additional value and improve business processes and patient outcomes, maximize the benefits of standardization of technologies and leverage across sites.

• Determine business criticality and product quality requirements, and in collaboration with Delivery Service Managers, ensure appropriate service levels, Disaster Recovery procedures, governance, change management, compliance and operational support.

• Lead or coordinate technical discussions and vendor negotiations.

• Lead proposal development for local and global digital governance bodies, collaborate with Site IT Business Partner to meet the needs of the Holly Springs Manufacturing.

• Through Agile delivery model, provide leadership, technical expertise and local implementation experience as a member of Build and Run Squads.

• In collaboration with IT Business Partners, monitor and improve stakeholder and user experience and ensure strong support of Product Transfers and Make/Assess/Release.

• Lead people: Site MES Lead with People Leadership responsibilities for all site MES Engineers

Who You Are

• Bachelor's or Master's degree in Engineering (Chemical, Mechanical, Electrical, or Computer Science preferred) and 10 years experience, or Master's degree in Engineering (Chemical, Mechanical, Electrical, or Computer Science preferred) and 8 years experience.

• Minimum of 5 years Pharmasuite MES experience, preferably majority in drug product function

• 24X7 support, participate in an on-call environment to meet business continuity requirements, including weekends and holidays as required.

Knowledge, Skills and Abilities

• Deep expertise with MES System implementation and Recipe Authoring, preferably in PharmaSuite MES

• Biopharmaceutical or similar Manufacturing domain.

• Knowledge of informational and operational technologies (IT OT), MES integration to enterprise systems.

• Knowledge of Manufacturing Execution System, Manufacturing Automation, MES integration with enterprise systems like LIMS, Data Historian, ERP etc.

• Knowledge of new product introduction, supply chain and manufacturing operations as applicable to MES.

• Keep abreast of key Manufacturing IT trends and be curious - Industrial IoT, Manufacturing Digital Plant Maturity, Cybersecurity, Pharma 4.0, Data Integrity principles, technology, and data standardization, etc.

• Nurtures and develops a business savvy consultative and value-driven partnership with key stakeholders

• Exhibits intellectual curiosity and integrity and has a strong passion to bring value-adding technology to the business.

• Knowledge of Good Manufacturing Practices (GMP), Health Authority practices, 21 CFR Part 11,cGMP Annex 11, Data Integrity principles.

Relocation funding is available for this role.

The expected salary range for this position based on the primary location of Holly Springs, North Carolina is $114,400 - $212,400. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. 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.

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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