ITOT PI & Integration Layer Architect

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

Job Overview:

• We are seeking an experienced IT PI & Integration Layer System (such as File Transfer SCADA MQTT and etc.) Architect with deep knowledge of the pharmaceutical/biotech industry to design govern and evolve our enterprise IT PI & Integration Layer architecture. This role will ensure our IT 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.
  

MainTasks & Responsibilities:

Architecture Strategy & Governance

• Develop and maintain enterprise IT PI & Integration Layer architecture roadmap including application data infrastructure cloud and security architecture.
• Establish architecture standards principles frameworks and governance processes to ensure consistency and compliance across the organization.
• Evaluate new technologies (cloud digital data analytics IoT AI/ML) and provide architectural recommendations for business and digital transformation.

Solution & System Design

• Lead architecture design for PI & Integration Layer System (such as File Transfer SCADA MQTT and etc.)
• Provide technical oversight for projects validate solution designs and ensure alignment with enterprise architecture and compliance rules.
• Conduct architecture reviews risk assessments and gap analysis for system implementation upgrade and integration.

Compliance & Regulatory

• Ensure all IT PI & Integration Layer System architecture and solutions meet GxP ALCOA data integrity GMP GDP cybersecurity and relevant regulatory requirements.
• Support regulatory audits (FDA EMA NMPA etc.) and internal/external IT compliance assessments.
• Define controls for system validation access management audit trails data retention and business continuity.

Integration Data & Security Architecture

• Design enterprise integration architecture (MES Equipment Automation ERP and etc.) and ensure seamless data flow across systems.
• Develop data architecture standards: master data management data quality metadata data lifecycle management.
• Collaborate with cybersecurity team to define security architecture identity management encryption and disaster recovery.

Stakeholder Collaboration & Governance

• Partner with business stakeholders (Manufacturing Quality Engineering Warehouse) to translate business needs into technical architecture.
• Work with vendors system integrators and project teams to enforce architectural standards.
• Provide technical leadership mentoring and architecture consulting to IT teams.

Qualification and Experience

Education/Qualifications

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

Job Required Competencies

• 7 years or above PI system related experience at least 3 years experience of PI Project Manager/Designer/Architect
• Have GMP working experience or have pharmaceutical working experience is preferred.
• Language skills: Good at listening speaking reading and written English
• System: OSI Soft PI (familiar with PI AF EF PI Vision)File Transfer SCADA

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.