Global Automation Standards & Governance Lead

Position Summary

Innovative Medicine Supply Chain (IMSC) is seeking a highly motivated individual to join the Global Engineering & Technology (GET) Automation organization 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, including sites in Belgium, Ireland, Netherlands, Italy, Switzerland, Puerto Rico and the United States.

Responsibilities and Impact

• Develop globally accepted Automation Standards supporting all Process Automation System (PAS) platforms across Biotherapeutic & Synthetic manufacturing sites.
• Ensure robust, fit for purpose design standards and promote standardization where it adds value.
• Champion the implementation of these standards across the manufacturing network.
• Own governance of Automation standards and act as gatekeeper for global library changes.
• Monitor adherence to standards and identify opportunities for improvement.
• Own Automation global libraries, recipe management, process control and data historian activities related to batch production, testing and release.
• Develop and maintain a roadmap of current and future Process Automation Systems aligned with the standards.
• Provide expert input for all Automation architecture/OT (Operational Technology) network infrastructure at Level2.5.
• Contribute to plant technology strategies and plans, and support uptime, maintenance, reliability and cost effectiveness of the platform environment.
• Support continuous improvement across all Process Automation System platforms.
• Collaborate with Automation Leads across Synthetic and Biotherapeutic sites to harmonize solutions and share best practices.
• Maintain strong connections with internal and external industry experts (e.g. ISPE) and thought leaders.
• Ensure alignment with enterprise wide strategies, compliance requirements and technology roadmaps.

Qualifications

Education: Bachelor's degree (BS) in Engineering, Science or related discipline.

Experience: Minimum 12 years in a manufacturing environment; at least 10 years in an Automation, OT or IT role within a pharmaceutical or GMP regulated setting.

Technical Skills: Proven leadership of cross functional teams and global automation initiatives; deep understanding of PLCs, SCADA, DCS and integration with MES and IT; expertise in ISA S95 and S88; knowledge of cGMP regulations, 21 CFR Part11 and EU GMP Annex11; experience with CSV, GAMP, ISPE and Industry4.0.

Communication & Leadership: Strong stakeholder management; ability to influence across global teams; proven track record of driving innovation and feasibility studies; strategic mindset and hands on capability for design, implementation and troubleshooting.

Languages: Fluent in English; proficiency in Dutch, Spanish, Italian or German is an advantage.

Travel: Up to 25% domestic and international travel.

Benefits

Base pay ranges vary by location. Additional benefits include annual bonus, vacation days, parental leave (minimum 12 weeks), bereavement and caregiver leave, volunteer leave, well being reimbursement, financial, physical, and mental health programs, service anniversary awards and eligibility to participate in various insurance plans. For further details, visit the company benefits site.