обновлено 5 дней назад
Manufacturing Execution System (MES) Project Lead (MES)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Manufacturing Execution System (MES) Project Lead (MES): Leading the implementation of an integrated Manufacturing Execution System for pharmaceutical manufacturing operations in Gurabo with an accent on digital workflows, system integration, and regulated manufacturing requirements. Focus on delivering the site transformation within scope, schedule, budget, quality, and regulatory constraints, aligning cross-functional stakeholders, and preparing the organization for the sustain phase.
Location: Gurabo, Puerto Rico, United States of America; onsite site deployment role
Employment type: Full time
Company
Johnson & Johnson MedTech develops healthcare and pharmaceutical solutions, including innovative medicines and medical technologies.
What you will do
- Lead delivery of the MES project for BioTherapeutics, Synthetics, and Drug Product operations at the Gurabo site.
- Drive the transformation from document-based manufacturing records to integrated digital workflows.
- Coordinate integration with manufacturing equipment, SAP, LIMS, TruVault, and other site and enterprise platforms.
- Own end-to-end execution across scope, schedule, budget, quality, and regulatory requirements.
- Align stakeholders, manage change, provide steering updates, and support issue escalation.
- Prepare the organization for the sustain phase after project completion.
Requirements
- Bachelor’s degree required; Science, Engineering, or a related discipline preferred.
- At least eight years of relevant experience in pharmaceutical manufacturing, operations, automation, digital transformation, or project management.
- Strong knowledge of pharmaceutical regulations, validation principles, quality requirements, and GMP regulations.
- Ability to lead cross-functional teams in a global matrix through influence, negotiation, and partnership.
- Strong decision-making, problem-solving, execution leadership, and stakeholder-alignment capabilities.
- Fluent English required; Spanish proficiency strongly preferred.
Nice to have
- Advanced degree in Life Sciences, Pharmacy, Chemical Engineering, Automation, Information Technology, or a related field.
- Understanding of GAMP, SDLC, and computerized system lifecycle requirements.
- Knowledge of automation, MES, and IT systems in regulated manufacturing environments.
Culture & Benefits
- Inclusive work environment centered on diversity, dignity, and equal opportunity.
- Work on healthcare innovations and pharmaceutical manufacturing transformation.
- Travel of up to 5% may be required.
- Inclusive interview accommodations are available for applicants with disabilities.
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