Manufacturing Execution System (MES) Project Lead
2162-Janssen Ortho LLC Legal Entity
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Job summary
Johnson & Johnson in Gurabo, Puerto Rico, seeks a Manufacturing Execution System (MES) Project Lead to drive a major site transformation. You will lead the project team, coordinate with the NGM program and Deployment Excellence, and deliver an integrated MES solution across BioTherapeutics, Synthetics and Drug Product platforms.
The role requires 8+ years in pharma manufacturing, strong GMP knowledge, and proven cross-functional leadership in regulated environments.
Qualifications
- Bachelor’s degree required; advanced degree preferred.
- Eight+ years of pharma manufacturing, operations, automation, digital transformation, or project management experience.
- Strong GMP knowledge and regulatory quality requirements in a regulated environment.
- Demonstrated ability to influence and partner across a global matrix organization.
- Strong decision-making, problem-solving, and execution leadership capabilities.
- Leadership presence to align cross-functional teams around a transformation agenda.
Responsibilities
- Lead end-to-end MES project delivery for Gurabo site within scope, schedule, budget, and quality constraints.
- Drive deployment excellence and integrate new capabilities into the Next Gen MES platform.
- Ensure sustained deployment readiness and stakeholder alignment across functions.
Skills
Education
Job description
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.
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:
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).
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
- 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
- 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
- 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
- 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
- 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
- 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
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 https://www.jnj.com/.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource. If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check
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