Transcend: Engineering Systems Lead

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:

Raritan, New Jersey, United States of America

Job Description:

About Innovative Medicine

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 for a Transcend: Engineering Systems Lead to join our team. This is an onsite role located in Raritan, NJ.

Transcend is a global business transformation program that will modernize our foundational transactional processes and harmonize them into one "clean" ERP as a standardized platform for growth and efficiency gains.

This program will simplify the Pharmaceutical ERP landscape from 7 to 1, standardizing processes to have a cost-effective, fit-for-purpose digital backbone that will enable us to support the Pharmaceutical business with agility. Additionally, the program will remediate the end-of-life system exposure that we risk towards the end of this decade.

Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality and reliable supply of our cell therapy products? Apply today for this exciting opportunity to be part of the #CAR-T team!

Johnson & Johnson Innovative Medicines and Legend Biotech have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy for BCMA. This strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR-T platform treatment.

Summary

The Engineering Systems Lead will serve as the System Lead for all engineering systems (including, but not limited to, Kneat, Engineering Repository, IBM Maximo, and related applications). This role owns technical and functional governance, leads upgrades and integrations, verifies data integrity, and conducts system and process audits to maintain GxP and organizational compliance.

Key Responsibilities

• Serve as the System Lead and single point of accountability for GxP and engineering platforms, including Kneat, IBM Maximo (CMMS/AMS), and Engineering Repository systems

• Own the end‑to‑end system lifecycle, from business requirements definition through validation, release, and ongoing operation

• Define, maintain, and manage system requirements and specifications with full traceability from business need through testing and deployment

• Plan and oversee system upgrades, patches, and new deployments, including impact assessments, UAT strategy, data migration, cutover, and rollback planning

• Lead Computer Systems Validation (CSV) activities in accordance with GAMP 5 and quality system expectations, ensuring systems remain in a validated state

• Establish and enforce data integrity and data quality controls, including master data governance, migration validation, and reconciliation activities

• Approve and oversee data migration strategies, including mapping, transformation, loading, and verification

• Coordinate and support system integrations and interfaces, working closely with IT, data, and cybersecurity teams

• Plan and execute internal system and process audits; manage audit findings, deviations, CAPAs, and system‑related change controls

• Identify, assess, and mitigate technical, business, and compliance risks; implement compensatory controls where required

• Design and deploy optimized, system‑enabled business processes to improve engineering, maintenance, and operational performance

• Collaborate with engineering, manufacturing, quality, maintenance, calibration, facilities, and program management stakeholders

• Lead system issue resolution and root cause investigations, ensuring timely and sustainable corrective actions

• Ensure ongoing regulatory compliance, audit readiness, and adherence to applicable safety, quality, and customer requirements

• Develop and maintain system knowledge management and training strategies to support user adoption and SME sustainability

• Support new product introductions by ensuring system configuration, data readiness, and process alignment

Qualifications

Education:

• Bachelor's degree in Engineering (Computer, Electrical, Mechanical, or related field) is required.

• Master's degree in Engineering, Business, or related field is preferred.

Experience and Skills:

Required:

• Minimum 8 years of experience in systems engineering, system ownership, or system integration within regulated industries (pharma, biotech, medical devices, or similar).

• System or Business Owner experience for engineering applications such as CMMS, SAP PM/MM, IBM Maximo, or equivalent systems.

• Experience leading at least one full enterprise system implementation (site, regional, or global) in a GxP environment.

• Strong knowledge of systems engineering concepts and the computer system validation (CSV) lifecycle.

• Experience with master data governance, reporting, and data analytics.

• Hands‑on data migration experience, including mapping, transformation, loading, and verification.

• Clear, effective communication skills, written and verbal, with cross‑functional stakeholders.

Preferred:

• Experience in pharmaceutical or medical device industry

• Supervisory experience preferred

• Experience with SAP Business Intelligence

• SQL skills (basic to advanced)

• Familiarity with GMP, ISO 55000, and ISPE GAMP 5

• Asset Management, CMMS, Computer Systems Validation (CSV)

• Change Management, CAPA, deviation handling

• Project Management, configuration and requirements management

• SOP development and maintenance

• Data analysis, reporting, and operational dashboards

• Benchmarking and process improvement

Other:

• Requires up to 20% domestic and/or international travel

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.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Artificial Intelligence (AI), Continuous Improvement, Critical Thinking, Industry Analysis, Innovation, Lean Supply Chain Management, Machine Learning (ML), Management Systems Implementation, Organizing, Process Improvements, Project Management, Prototyping, Quality Assurance (QA), Robotic Automation, Science, Technology, Engineering, and Math (STEM) Application, Subject Matter Experts (SME) Collaboration, Technical Credibility

The anticipated base pay range for this position is :

$102,000.00 - $177,100.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

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; for employees who reside in the State of Colorado- 48 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
• Bereavement Leave- 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave- 80 hours in a 52-week rolling period10 days
• Volunteer Leave- 32 hours per calendar year
• Military Spouse Time-Off- 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits