MES Architect
Share
Job Location:
Monthly Salary:
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.
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. MainTasks & 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 100000 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.
Lets build a healthier future together.
Roche is an Equal Opportunity Employer.
Required Experience:
Staff IC
Key Skills
About Company
F. Hoffmann-La Roche AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange. The company headquarters are located in Basel.
