Global Automation Standards & Gov. Lead

Johnson & Johnson Innovative Medicine•Gurabo, PR

6d•Onsite

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Position Summary The GET (Global Engineering & Technology) organization operates as an integrated team in the delivery of Process Engineering, Project Execution, Maintenance and Automation solutions. We operate in a standard, coordinated and consistent manner in support of the current and future requirements of our Manufacturing and Manufacturing Science and Technology (MSAT) groups and in partnership with key internal/external networks. As the GET, Automation Standards & Governance Lead, they will develop, own, implement, and govern the Automation Standards across all Process Automation System (PAS) platforms that support the Biotherapeutic & Synthetic Sites. Joining our global engineering group, you will have the opportunity to collaborate with individuals who consistently demonstrate strong work behaviors from various functions and sites within IMSC. This dynamic and inspiring work environment offers endless possibilities for personal and professional growth.

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.

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.