Roche · 2 months ago
Senior Principal MES Engineer (CVRM)
Holly Springs
Full-time
Hybrid
Senior Level, Lead/Staff
$114K/yr - $212K/yr
8+ years expRoche is a global healthcare company that focuses on delivering innovative therapies. They are seeking a Senior Principal MES Engineer to lead the implementation and long-term support of Manufacturing Execution Systems for a new manufacturing site in Holly Springs, North Carolina.
BiotechnologyHealth CareHealth DiagnosticsOncologyPharmaceuticalPrecision Medicine
Responsibilities
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
Qualification
Required
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
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
Benefits
Relocation funding is available for this role.
A discretionary annual bonus may be available based on individual and Company performance.
Company
Roche
Roche is a pharmaceutical and diagnostics company that offers medicines and diagnostic tests for various medical conditions and diseases.
10001+ employees
H1B Sponsorship
Roche has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (12)
2024 (9)
2023 (6)
2022 (2)
2021 (2)
Funding
Current Stage
Public CompanyTotal Funding
$7.79BKey Investors
SoftBankSCALE AINovartis
2021-08-04Post Ipo Equity· $5B
2020-12-07IPO
2020-05-06Post Ipo Equity· $0.5M
Leadership Team
Alan Hippe
Member of the Executive Board - Group CFO
Christine Bakan
Global Head and VP of Software and Bioinformatics, Next Generation Sequencing
Recent News
Pharmaceutical Technology
2026-01-13
2026-01-12
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