Define and execute the global Operational Technology (OT) strategy and roadmap for manufacturing and QC systems, ensuring alignment with I&T and business strategies.
Advance paperless, recipe-driven, and data-integrated execution aligned to ISA-88/95 and Pharma 4.0 principles.
Prioritize OT initiatives that enhance productivity, regulatory compliance, and manufacturing reliability.
Communicate OT strategy, value realization, and roadmap progress to executive and site leadership.
Provide lifecycle ownership for Enterprise GxP manufacturing and lab OT platforms including OSI Pi, LIMS, Enterprise MES, Edge, Configuration management, and other enterprise tools.
Ensure platforms meet operational, compliance, and performance standards across global sites.
Drive harmonization and modernization of Enterprise OT platforms and support the roadmap for site integrations.
Lead enterprise OT governance structures (Design Authority, Standards Council, etc.).
Define global OT standards for configuration, recipes, data, and cybersecurity in alignment with I&T, C&Q/CSV, GAMP 5 and GxP requirements.
Maintain validated, secure, and interoperable architectures between plant-level systems and enterprise data layers.
Ensure OT environments adhere to 21 CFR Part 11, Annex 11, and digital validation best practices.
Accountable for Tier 1 capital project delivery for manufacturing and QC digital platforms.
Govern Tier 2/3 site projects to ensure adherence to global OT standards, validation, and cybersecurity requirements.
Manage readiness, commissioning, and hypercare for OT systems introduced via T1 capital or digital programs.
Lead the global OT organization encompassing Lab Systems, Data Systems, Recipe Standards, and Innovation & Partner Enablement.
Define best practices, playbooks, and training for site automation and lab teams.
Build global OT capabilities, talent pipelines, and competency frameworks.
Manage OT budgets (opex/capex) and resource allocation to maximize enterprise value.
Provide a positive and equitable working environment, emphasizing values such as Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance.
Develop and manage strategic partnerships with automation, MES, historian, and lab system platform providers.
Align supplier roadmaps to OT strategy and ensure service excellence, cost optimization, and innovation delivery.
Collaborate closely with I&T, Operations, Technical Operations, Quality, Validation, and Data Analytics while retaining ownership of the OT domain.
Identify and pilot emerging OT and industrial digital technologies (AI/ML at the edge, digital twins, composable MES, Cloud, etc.).
Requirements
Bachelor of Science in an Engineering, Automation, Computer Science or local equivalent.
15+ years’ work experience, with at least 5 years’ experience in execution systems, operational technology, IT and operations.
Specific experience in process automation, MES and batch manufacturing industry standards (ISA S88 &S95).
Direct experience designing, building, deploying and supporting automation and execution systems (SCADA, DCS, MES, PAT, LIMS, Digital Methods, OSI Pi Data historian, etc.) in a regulated large-scale process-based manufacturing environment.
Experience in running site-based shop floor and laboratory systems in a globally distributed footprint is highly desirable.
A proven track record of influencing the industry on operational technology via publications and presentations is strongly preferred.
Experience building, managing, and deploying high performing, innovative and transformational process automation / execution systems across a global organization.
Demonstrated ability to influence at all organizational levels through clear, concise and impactful verbal and written communication skills.
Ability to build, mentor and grow a high performing and cohesive team.
Experience in Process Excellence methodology is desirable but not required.
Ability to work across a range of countries and cultures.
Demonstrated experience in managing leaders, employees, and cross-functional project teams.
Strong project management skills and experience in engineering projects within biopharma manufacturing.
Functional knowledge of cGMPs and manufacturing operations in FDA-regulated facilities.