Global Automation Standards - Governance Lead

Responsibilities

• Responsible for the development of global Automation Standards that support all Process Automation System (PAS) platforms, i.e.: Emerson DeltaV, Siemens PCS-7, Aveva Wonderware, etc. across all IM SC Biotherapeutic & Synthetic manufacturing sites.
• Ensure robust, fit-for-purpose design standards and promote standardization where it adds value.
• Responsible for implementation of these Standards across the manufacturing network as the champion for the utilization of standards.
• Owns the governance of Automation standards and acts as gatekeeper for global library changes.
• Continuously monitors adherence to the standards and identify opportunities for improvement.
• This also includes ownership of Automation global libraries, recipe management, process control, and data historian activities related to batch production, testing and release.
• Develop and maintain a road map of current and future Process Automation Systems (PAS) aligned with the developed standards.
• Responsible for developing global standards and providing expert input for all Automation architecture/OT (Operational Technology) network infrastructure installed at Level 2.5.
• Take ownership of and contribute to the development of plant technology strategies and plans.
• Also responsible for contributing to the uptime & maintenance of a functional, reliable, and cost-effective platform environment for the assigned areas.
• Support continuous improvement in identifying potential improvements across all Process Automation System platforms.
• Actively collaborate with Automation Leads across Synthetic and Biotherapeutic Sites.
• Identify opportunities for harmonization, share solutions, and best practices.
• Foster a culture of collaboration to reduce duplication and accelerate implementation.
• Maintain strong connections with industry experts (internal and external, e.g. ISPE) and thought leaders to bring cutting edge solutions into the organization.
• Ensure alignment with enterprise-wide strategies, compliance requirements, and technology roadmaps.

Requirements

• BS. Degree in Engineering, Science or related discipline.
• A minimum of 12 years of experience in a manufacturing environment, preferably within the biopharmaceutical or pharmaceutical industry, including at least 10 years of proven experience in an Automation, OT or IT (Information Technology) role within a pharmaceutical or GMP regulated manufacturing environment.
• Proven track record in leading cross functional teams and driving global initiatives in automation and process control.
• Deep understanding of industrial automation systems, including PLCs, SCADA, DCS, and integration with MES and IT systems.
• Expertise in ISA S95 and S88 standards and their application within the Global Supply Chain.
• Knowledge of cGMP regulations related to Automation & Computer System Validation (CSV), including 21 CFR Part 11 and EU GMP Annex 11 in an FDA regulated environment.
• Strong stakeholder management and communication skills, with the ability to influence across global teams and external partners.
• Demonstrated ability to drive innovation, develop business cases, and lead feasibility studies.
• Familiarity with industry standards and networks such as ISPE, GAMP, and Industry 4.0 technologies.
• Strategic mindset with hands on capability to support design, implementation, and troubleshooting of automation solutions.
• Intellectual curiosity to challenge the status quo, influence without authority, and cultivate an inclusive and collaborative culture.
• Proficiency in written and spoken English, additional languages (Dutch, Spanish, Italian, German) would be a significant advantage.

Core Competencies

Demonstrates expertise in developing and implementing global Automation Standards across Process Automation Systems, ensuring compliance with cGMP regulations and fostering collaboration among cross functional teams. Possesses a strategic mindset to drive innovation and continuous improvement in automation solutions within the biopharmaceutical industry.