Senior IT/OT Solution Architect (Pharma Manufacturing)

Project overview

Senior IT/OT Solution Architect needed for a contract role in Germany (8–12 years) to drive system-level architecture decisions across the IT/OT stack in a pharma/biopharma manufacturing environment. The role covers defining interfaces, data flows and integration specifications; supporting requirements engineering and detailed design documentation; providing hands-on technical assistance (including source-code components when required); and contributing to testing, qualification/commissioning, hypercare and operational support.

Strong Business–IT–OT collaboration, multi-supplier coordination, GMP/non-GMP awareness, and availability for mandatory on-site qualification/configuration/testing are required. Roche qualification-process knowledge is highly desirable.

Responsibilities

• Pharma/biopharma industry experience; GMP/non-GMP awareness; effective Business-IT-OT collaboration; multi-supplier coordination; availability for mandatory on-site qualification, configuration and testing activities. Roche qualification-process knowledge is highly desirable.
• 2 Define system interactions, interfaces, data flows and technical integration specifications.
• 3 Support requirements engineering and create detailed design documentation.
• 4 Provide operative technical assistance, including source-code components where required.
• 5 Support integration across manufacturing, laboratory and automation systems.
• 6 Contribute technical input to test, qualification, commissioning, hypercare and operational support.
• 7 Support adaptation of the PTCG IT/OT manufacturing blueprint with other business units.

Requirements

• Pharma/biopharma industry experience
• GMP and non-GMP awareness (regulated vs non-regulated environments)
• IT/OT architecture across manufacturing/lab/automation systems
• System integration: defining system interactions, interfaces, and data flows
• Technical integration specifications and detailed design documentation
• Requirements engineering support (translating requirements into technical design)
• Hands-on technical assistance, including source-code components when required
• Support for testing, qualification, commissioning, hypercare, and operational support
• Business–IT–OT collaboration and stakeholder alignment
• Multi-supplier/vendor coordination
• Availability for mandatory on-site qualification, configuration, and testing activities (Germany)

Project details

• Start: flexible
• Remote: hybrid
• Location: Germany, DE