Manufacturing Execution System (MES) Project Lead

Johnson & Johnson Innovative Medicine; Gurabo (PR); On-site; USD 110,000 - 170,000; Full time

Job summary

Johnson & Johnson is seeking a Manufacturing Execution System (MES) Project Lead at the Gurabo site to steer a major digital transformation. You will lead the MES deployment across BioTherapeutics, Synthetics and Drug Product, coordinating with site teams and the NGM program to deliver an integrated, compliant digital workflow.

The role requires strong leadership, program management expertise, and experience with GMP, SDLC, and IT-enabled manufacturing.

Qualifications

• Minimum eight years of experience in pharmaceutical manufacturing, operations or automation.
• Knowledge of GMP regulations and quality requirements in regulated pharma environments.
• Ability to work across a global matrix with stakeholders at multiple levels.

Responsibilities

• Lead the MES project for Gurabo site within BioTherapeutics, Synthetics and Drug Product platforms.
• Serve as primary contact between site project team, sponsor and steering committee.
• Ensure alignment of objectives and deliver an integrated MES solution for Gurabo.
• Drive disciplined execution and deployment readiness across all workstreams.
• Set up organization for sustain phase after project completion.

Skills

AI

Compliance Management

Developing Others

Inclusive Leadership

Innovation

Leadership

Lean Supply Chain Management

Management Systems Implementation

Operations Management

Process Improvements

Science

Technology

Engineering

Math (STEM) Application

Team Management

Workflow Automation

Education

Bachelor’s degree in Science, Engineering or related discipline

Advanced degree in Life Sciences, Pharmacy, Chemical Engineering, Automation, IT, or related field

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:

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:

• 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

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