Global Automation Standards & Gov. Lead
Johnson & Johnson Innovative Medicine · Athens, GA · 2 wk ago
HybridManagementFull-time
Position Summary
Innovative Medicine Supply Chain (IMSC) is seeking a highly motivated individual to join the Global Engineering & Technology (GET) Automation organization at Johnson & Johnson as global Automation Standards & Governance Lead supporting Synthetics and Biotherapeutics Sites. This is a unique opportunity to make a significant impact in a global role based at one of our major manufacturing locations (Beerse/Geel, Belgium; Cork, Ireland; Leiden, The Netherlands; Latina, Italy; Schaffhausen, Switzerland; Gurabo, Puerto Rico; Athens, Georgia, USA).
Responsibilities And Impact
- Develop, own, implement, and govern the Automation Standards across all Process Automation System (PAS) platforms that support the Biotherapeutic & Synthetic Sites.
- Ensure robust, fit-for-purpose design standards and promote standardization where it adds value.
- Implement 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.
- Develop and maintain a road map of current and future Process Automation Systems (PAS) aligned with the developed standards.
- Support continuous improvement in identifying potential improvements across all Process Automation System platforms.
- Collaborate with Automation Leads across Synthetic and Biotherapeutic Sites.
- 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.
Qualifications
- Education: BS. Degree in Engineering, Science or related discipline.
- Experience And Skills: 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.