This role establishes the global governance framework for operational technology partners delivering services across GxP manufacturing and laboratory systems
Job Summary
This role establishes the global governance framework for operational technology partners delivering services across GxP manufacturing and laboratory systems.
The position is responsible for defining shared service operating models, including SLAs, KPIs, and contract templates for strategic OT suppliers.
Candidates must ensure partner-delivered projects adhere to FDA-regulated facility standards while driving cost-effective and reliable execution.
Matching Summary
This role establishes the global governance framework for operational technology partners delivering services across GxP manufacturing and laboratory systems.
Skills & Requirements
Must-have
10+ years work experience in execution systems
Direct experience with MES, SCADA, DCS, LIMS
Knowledge of ISA S88 and S95 standards
Expertise in GxP regulatory compliance and cGMPs
Experience managing Master Service Agreements
Nice-to-have
Strong project management skills in biopharma
Ability to work across multiple countries and cultures
Strategic innovation and stakeholder engagement
Experience with OSI PI Data historian platforms
Key Requirements
Bachelor of Science in Engineering, Automation, or Computer Science
Minimum 10 years of work experience
At least 5 years in operational technology and execution systems
Functional knowledge of cGMPs in FDA-regulated facilities