Transcend: Engineering Systems Lead

Johnson & Johnson Innovative Medicine•Raritan, NJ

7d•$102,000 - $177,100•Onsite

About The Position

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. 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.

Requirements

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

Nice To Haves

Master’s degree in Engineering, Business, or related field is 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

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

Benefits

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