Manufacturing Execution System Automation Lead

Johnson & Johnson; Malvern (Chester County); On-site; USD 94,000 - 145,000; Full time

Benefits offered by this job

Employee benefits

Job summary

Johnson & Johnson in Malvern, PA is seeking an experienced MES Lead to guide manufacturing automation projects. You will lead a team supporting PAS-X MES, validate processes, and ensure compliance with cGMP and FDA standards while collaborating with Quality, IT, and Lab Systems.

This role anchors digital manufacturing initiatives across sites. The ideal candidate has 6+ years in MES, strong leadership, and a deep understanding of regulatory requirements.

Qualifications

• Bachelor's degree in engineering required.
• Minimum 6 years MES-related experience.
• Experience with PAS-X MES and manufacturing automation.
• Strong communication and leadership skills.
• Knowledge of cGMP and FDA regulations is preferred.

Responsibilities

• Support PAS-X MES, configure interfaces, ensure compliance with standards.
• Lead MES engineering programs and manage cross-functional teams.
• Coordinate validation, risk assessments, and GMP audits.
• Develop global standards and drive digital manufacturing initiatives.

Skills

MES

PAS-X

Digital manufacturing

OSI PI

Leadership

Education

Bachelor's degree in Engineering

Tools

Lean Six Sigma

GxP knowledge

FDA regulations

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

Scientific/Technology

All Job Posting Locations

Malvern, Pennsylvania, 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, Manufacturing Execution System Automation Lead This position can be based in Malvern and Spring House Pennsylvania. The Engineering organization operates as one integrated team in the delivery of Project Execution, Maintenance and Automation activities. This occurs in a standard, coordinated and consistent manner in support of the current and future requirements of our organization and in conjunction with key partners, to create one integrated internal/external network. The automation engineering team is a dedicated team of enthusiastic and skilled automation professionals with various technical expertise, responsible for the (support of) implementation, validation, qualification and maintenance of the ISA-95 level 1 and 2 manufacturing automated systems and applicable interfaces and level 3 recipe content for the manufacturing facility. We ensure that automated systems are fit for intended use and follow applicable regulatory requirements (e.g. cG(a)MP) and company manufacturing standards throughout the entire system life cycle. This is a multi-site role supporting MES at both the Malvern and Spring House PA facilities.

The responsibilities and the impact YOU will have

Support the PAS-X manufacturing execution system (MES), configure interfaces, ensure compliance with global standards, write and perform validation protocols, participate in compliance inspections, hold and support risk assessments, and support investigations. Ensure sound technical engineering concepts are applied in all tasks. Define project scope and ensure resources, capabilities and processes are in place. Develop a mechanism to proactively assess business needs and to identify points of use across functional groups in the Platform. Act as project leader/core team member by tracking cost, quality, and schedule to ensure an effective management of project execution. Ensure programs stay on target through accurate resourcing and removing obstacles, which may involve communication at a senior level within the business. Establish effective working relationships with Quality, IT, Lab Systems, Procurement, and others and develop new partnerships to optimize processes. Help transform the site with new digital technology including multi-variable analysis, advanced process control, and digital visualization tools.

Lead MES Engineer Lead a team of internal and external MES engineers. Manage and lead a large program of projects. Implement or lead execution system code change, perform or lead validation, ensure that site and global standards are met, lead risk assessments, lead GMP audits as team representative. Manage an off-shift support team to ensure 24/7 operation of the site. Develop global standards and participate on standardization teams. Participate in site business planning as a team representative.

Requirements

We would love to hear from YOU, if you have the following essential requirements: Capabilities identified as priority for our Workforce of the Future are: Digital & Technology Change Leadership Critical Thinking & Problem Solving Process knowledge & expertise End to End mindset Education: Minimum of a Bachelor's or equivalent degree in Engineering required Experience and Skills: Required: Experience in PAS-X Manufacturing Execution System (MES) Excellent written and verbal communication skills Strong decision making and problem-solving skills, with demonstrated ability to think strategically and lead change Preferred: Knowledge of cGMPs and FDA regulations Experience, training, or certification in Process Excellence tools (Lean, Six Sigma) Solid understanding of historians such as OSI PI Knowledge of integration between MES and automation systems Knowledge of technology development and validation, including design of experiments and statistical analysis. Qualifications: A technical education / degree in industrial automation, information technology or relevant engineering field is required. Experience in GxP regulated environment and a related position is required: Minimum of 6 year’s MES relevant experience.

What awaits YOU at J&J

An opportunity to be part of a global market leader. A dynamic and inspiring working environment. Career opportunities and continuous personal and professional development in areas of technology and leadership. Personal Development Plan – such as access to further education & training, mentoring and coaching, development opportunities on-the-job or through exciting projects. Be part of a strong global network of talent and expertise, with opportunities to learn or move to different cultures and work environments. Many employee benefits.

Equal Opportunity Employer

We are an equal opportunities employer. 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.

Salary

The anticipated base pay range for this position is : 94,000-144,500

Additional Description for Pay Transparency

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits:

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
• Caregiver Leave – 10 days
• Volunteer Leave – 4 days
• Military Spouse Time-Off – 80 hours

Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

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/.

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