Johnson & Johnson
Malvern, PA
Shift: Full time
At Johnson Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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/innov ative-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. 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