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The Position

1.   Job Overview:

We are seeking an experienced ITOT MES System Architect with deep knowledge of the pharmaceutical/ biotech industry to design, govern, and evolve our enterprise ITOT MES System architecture. This role will ensure our ITOT systems are compliant, scalable, secure, resilient, and aligned with GxP, data integrity, and regulatory requirements (FDA, EMA, NMPA, GMP, GDP, etc.), while supporting Manufacturing, Quality, Engineering, Warehouse and other functions.

2. Main Tasks & Responsibilities:

The position should be responsible for MES Architect, System Configuration and Recipe related work.

2.1 MES Architect
2.1.1 Architecture Strategy & Governance
a) Develop and maintain enterprise ITOT MES System architecture roadmap, including application, data, infrastructure, cloud, and security architecture.
b) Establish architecture standards, principles, frameworks, and governance processes to ensure consistency and compliance across the organization.
c) Evaluate new technologies (cloud, digital, data analytics, IoT, AI/ML) and provide architectural recommendations for business and digital transformation.

2.1.2 Solution & System Design
a) Lead architecture design for MES System, including solution, system configuration and Recipe design.
b) Provide technical oversight for projects, validate solution, system configuration and Recipe design, and ensure alignment with enterprise architecture and compliance rules.

c) Conduct architecture reviews, risk assessments, and gap analysis for system implementation, upgrade, and integration.

2.1.3 Compliance & Regulatory
a) Ensure all ITOT MES System architecture and solutions meet GxP, ALCOA+, data integrity, GMP, GDP, cybersecurity and relevant regulatory requirements.
b) Support regulatory audits (FDA, EMA, NMPA, etc.) and internal/external IT compliance assessments.
c) Define controls for system validation, access management, audit trails, data retention, and business continuity.

2.1.4 Integration, Data & Security Architecture
a) Design enterprise integration architecture (MES, PI & Interface Layer, Equipment Automation, SAP and etc.) and ensure seamless data flow across systems.
b) Develop data architecture standards: master data management, data quality, metadata, data lifecycle management.
c) Collaborate with cybersecurity team to define security architecture, identity management, encryption, and disaster recovery.

2.1.5 Stakeholder Collaboration & Governance
a) Partner with business stakeholders (Manufacturing, Quality, Engineering, Warehouse) to translate business needs into technical architecture.
b) Work with vendors, system integrators, and project teams to enforce architectural standards.
c) Provide technical leadership, mentoring, and architecture consulting to IT teams.

2.2   MES System Configuration & Recipe

2.2.1        Design operation process, Responsible for ITOT MES system routine operation work including:

a)   MES System Configuration, Recipe and master data optimization, setting, testing, verification and related documentation.

b)   SAT, UAT support and MES training.

c)    MES system operation status tracking, incident and problem handling.

d)   MES operation quality analysis and ITOT process improvement.

e)   MES system security management.

f)     ITOT system client device and equipment management.

2.2.2    Support ITOT MES system project implementation or system upgrade (MES System Configuration, Recipe and master data related)

2.2.3    Support internal and external audit of ITOT system.

2.2.4    Support business opportunities enabled by ITOT information and technology.

2.2.5    Provide both tactical and strategic interface, technical consultation and co-create technology enabled business strategy in ITOT MAKE area.  

2.2.6    Support ITOT Manufacturing System Head to prioritize, challenge and advise to shape the right outcomes for customers and patients.

2.2.7    Work with process owner, system owner and other ITOT team members to Influence all ITOT delivery in MAKE (MES System Configuration, Recipe and master data related).

2.2.8    Design MES Recipe and master data management operation process, be responsible & coordinate cross team working for ITOT system routine master data management operation work for PT Shanghai MAKE business & clinic trail business.

3.    Qualification and Experience

Education/Qualifications教育程度/所获资格证书

Bachelor degree or above in related subject, computer or automation related subject is preferred

Job Required Competencies

10 years’ or above MES system related experience, at least 5 years’ experience of MES Architect/Recipe/Designer/Expert

Have GMP working experience, or have pharmaceutical working experience is preferred.

Language skills: Good at listening, speaking, reading and written English

System: Rockwell MES Pharma Suite System is preferred

Soft Skills:
• Excellent communication, presentation, and stakeholder management skills.
• Strong analytical, problem-solving, and project leadership abilities.
• Ability to balance business needs, compliance, security, and technology innovation.

Competencies:
• Strategic thinking & enterprise architecture vision
• Regulatory & compliance mindset in a validated environment
• Technical expertise & solution judgment
• Cross-functional collaboration & leadership
• Results-oriented and delivery-focused

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.