PI Lead

Johnson & Johnson Innovative Medicine • Malvern, PA

3d • Hybrid

About The Position

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 Lead PI Engineer to be located in Malvern or Springhouse Pennsylvania, . Johnson & Johnson: At Johnson & Johnson, we are working to create a world without disease! Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. 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 PI at both the Malvern and Spring House PA facilities.

Requirements

• Minimum of a Bachelor's or equivalent degree in Engineering required
• Experience in Aveva PI
• 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 experience.

Nice To Haves

• Knowledge of cGMPs and FDA regulations
• Experience, training, or certification in Process Excellence tools (Lean, Six Sigma)
• Knowledge of integration between MES and automation systems
• Knowledge of technology development and validation, including design of experiments and statistical analysis.

Responsibilities

• Support the Aveva PI system, 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 PI Engineer Lead a team of internal and external PI 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.
• 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