Manufacturing Execution System Automation Lead

6084-Janssen Research & Development, LLC Legal Entity; Malvern (Chester County); On-site; USD 94,000 - 144,500; Full time

Benefits offered by this job

Opportunity for career development

Flexible vacation and personal time

Comprehensive employee benefits

Job summary

6084-Janssen Research & Development, LLC Legal Entity is seeking a Manufacturing Execution System Automation Lead in Malvern, Pennsylvania. This role involves supporting, implementing, and maintaining automated systems in compliance with regulatory standards.

You will lead a team, manage large projects, and integrate new digital technologies while ensuring effective execution and adherence to quality standards. Candidates must have a bachelor's degree in engineering and extensive MES experience.

Qualifications

• Minimum of six years of MES relevant experience in a GxP regulated environment.
• Experience in PAS-X Manufacturing Execution System (MES).
• Strong understanding of integration between MES and automation systems.

Responsibilities

• Support the PAS-X manufacturing execution system (MES) and configure interfaces.
• Lead MES engineer team and manage project execution.
• Help transform the site with new digital technology.

Skills

Communication skills

Decision-making

Problem-solving

Knowledge of cGMPs

Knowledge of FDA regulations

Experience in PAS-X MES

Lean/Six Sigma tools

Education

Bachelor's degree in engineering or equivalent

Tools

OSI PI

Job description

Job Title

Manufacturing Execution System Automation Lead

Location

Malvern, Pennsylvania, United States of America; Spring House, Pennsylvania, United States of America.

Job Summary

Tasked with the support, implementation, validation, qualification, and maintenance of ISA‑95 level 1 and 2 manufacturing automated systems, including MES interfaces and level 3 recipe content, at both Malvern and Spring House facilities. The role ensures systems are fit for intended use, meet regulatory requirements such as cG(a)MP, and align with company manufacturing standards throughout the system life cycle.

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.
• Apply sound technical engineering concepts to all tasks.
• Define project scope and ensure resources, capabilities, and processes are in place.
• Develop a mechanism to proactively assess business needs and identify points of use across functional groups in the platform.
• Act as project leader or core team member by tracking cost, quality, and schedule to ensure effective project execution management.
• Ensure programs stay on target through accurate resourcing and remove obstacles, which may involve senior‑level communication within the business.
• Establish effective working relationships with Quality, IT, Lab Systems, Procurement, and others; 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 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 site and global standards are met, lead risk assessments, and 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.

Qualifications

• Minimum of a bachelor’s or equivalent degree in engineering.
• Minimum of six years of MES relevant experience in a GxP regulated environment.
• 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.
• 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.

Benefits

• Opportunity to be part of a global market leader.
• Dynamic and inspiring working environment.
• Career opportunities and continuous personal and professional development in areas of technology and leadership.
• Personal Development Plan, including access to further education & training, mentoring and coaching, and development opportunities on‑the‑job or through projects.
• 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, including vacation (120 hours per calendar year), sick time (40 hours per calendar year; 56 hours if in Washington state), holiday pay and 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 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), and military spouse time‑off (80 hours).
• Base pay range: 94,000–144,500.

Equal Employment Opportunity

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. Johnson & Johnson actively seeks qualified candidates who are protected veterans and individuals with disabilities under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an inclusive interview process and accommodations for applicants with disabilities. For external applicants requesting assistance, contact https://www.jnj.com/contact-us/careers. For internal employees, contact AskGS for accommodation resources.