Job Function: Supply Chain Engineering
Job Sub Function: Automation Engineering
Job Category:People Leader
All Job Posting Locations:Gurabo, Puerto Rico, United States of America
Job Description:About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine.
We are searching for the best talent for a Manufacturing Execution System (MES) Project Lead in Gurabo, PR! Are you ready to advance your career in Digital Transformation? Join our team!
The successful candidate will be responsible for leading the site project team to deliver a major site transformation program through implementation of a Manufacturing Execution System for the BioTherapeutics, Synthetics and Drug Product operations in Gurabo using new integrated technologies called the Next Gen Manufacturing platform. This will be a phased transformation involving conversion of manufacturing batch information and records from document-based processes to a fully integrated digital workflow environment. The system will be integrated with multiple key systems (e.g. manufacturing equipment, SAP, LIMS, TruVault and other site and enterprise platforms).
Role:- Lead and deliver the MES project in the BioTherapeutics, Synthetics and Drug Product platforms for the Gurabo site
- Serve as the primary contact between the project team, project sponsor and steering committee at the site and the NGM program and Deployment Excellence team
- Ensure project team representation is aligned with project objectives and delivers an integrated MES solution for the Gurabo business
- Act as the project leader and site deployment expert for Gurabo
- Champion disciplined execution, stakeholder alignment and deployment readiness
Responsibilities:- Own end-to-end execution and program delivery within scope, schedule, budget, quality and regulatory requirements
- Maintain strong partnerships to drive end-to-end deployment excellence for systems to co-develop and embed new technical capabilities into the Next Gen Manufacturing platform
- Hold overall accountability for successful, timely and on-budget execution of the deployment across all workstreams and functions
- Drive a strong change management process with all the stakeholders at the site to ensure they understand, support and drive the changes at their department, line and/or platform
- Manage the deployment to ensure timely, high-quality deliverables and strong right-first-time performance
- Partner with the Cross Deployment Leader to provide consistent communication, steering updates and escalation support to the Steering Committee and Project Sponsor
- Partner with the Business Lead to ensure the end-state integrated solution meets business needs across all impacted functions end-to-end
- Collaborate closely with the Next Gen MES Deployment Lead and Deployment Excellence Lead to define and execute deployment standards
- Set up and prepare the organization for the sustain phase after the completion of the project
Qualifications: Education- A minimum of a bachelor's degree is required; focused degree in Science, Engineering or related discipline is preferred
- An advanced degree in Life Sciences, Pharmacy, Chemical Engineering, Automation, Information Technology, or a related field is a plus
Experience Required- A minimum of eight (8) years of relevant experience in pharmaceutical manufacturing, operations, automation, digital transformation, and/or project management
- Strong knowledge of applicable regulations, validation principles and quality requirements in a regulated pharmaceutical manufacturing environment.
- Demonstrated knowledge of Good Manufacturing Practice (GMP) regulations
- Proven ability to work across organizational boundaries in a global matrix environment through influence, negotiation and partnership, while gaining buy-in from stakeholders at multiple levels
- Strong decision-making, problem-solving and execution leadership capabilities
- Strong leadership presence with the ability to align cross-functional teams around a shared transformation agenda
Preferred- Understanding of GAMP, SDLC, and computerized system lifecycle requirements
- Knowledge of automation, MES, and IT-related systems in a regulated manufacturing environment
Other- Fluency in English is required. Spanish proficiency is strongly preferred
- This position requires up to 5% of travel time
Required Skills: Preferred Skills:Artificial Intelligence (AI), Compliance Management, Developing Others, Inclusive Leadership, Innovation, Leadership, Lean Supply Chain Management, Management Systems Implementation, Operations Management, Process Improvements, Science, Technology, Engineering, and Math (STEM) Application, Team Management, Workflow Automation
