PI Lead

Job Function

Supply Chain Engineering

Automation Engineering

Scientific/Technology

Malvern, Pennsylvania, United States of America

Lead PI Engineer

• 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 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.

• Digital & Technology
• Change Leadership
• Critical Thinking & Problem Solving
• Process knowledge & expertise
• End to End mindset

• 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

• 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.

• 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.

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.

Base pay range: 94,

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 (56 hours per calendar year for employees who reside in the State of Washington), 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.