Manufacturing Execution System Automation Lead

Johnson & Johnson • Malvern, PA

1d • Hybrid

About The Position

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.

Requirements

• 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
• 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.

Nice To Haves

• 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.

Responsibilities

• 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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior