The role is accountable for establishing the strategic technical framework by which external partners deliver operational and capital OT services across GxP manufacturing systems
Job Summary
The role is accountable for establishing the strategic technical framework by which external partners deliver operational and capital OT services across GxP manufacturing systems.
This position requires defining global governance practices to ensure adherence to cGMPs, safety, and regulatory expectations in all partner-delivered services.
The company is a global biotherapeutics leader driven by a promise to save lives through innovative therapies delivered via plasma fractionation and recombinant protein technology.
Matching Summary
The role is accountable for establishing the strategic technical framework by which external partners deliver operational and capital OT services across GxP manufacturing systems.
Skills & Requirements
Must-have
10+ years work experience
Process automation and MES expertise
GxP regulatory compliance knowledge
ISA S88 and S95 standards
Master service agreement management
OT platform lifecycle governance
Nice-to-have
Cross-cultural collaboration skills
Strategic innovation mindset
Change management support
Enterprise KPI scorecard design
Cost-effective execution focus
Key Requirements
Bachelor of Science in Engineering or Computer Science
Minimum 10 years of work experience
At least 5 years in execution systems and OT
Direct experience with PCS, MES, OSI PI, and LIMS platforms