QCS Engineering Manager

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 https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Quality Systems

Job Category:

People Leader

All Job Posting Locations:

Malvern, Pennsylvania, United States of America, Milpitas, California, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Tampa, Florida, United States of America, Titusville, New Jersey, United States of America

Job Description:

We are seeking a QCS Engineering Manager, located at one of the following sites:  Skillman, Raritan NJ, Titusville NJ, Malvern PA, Springhouse PA, Milpitas, CA or Tampa, FL.

The Quality, Compliance, and Sustainability (QCS) Engineering Manager for Laboratory Systems will lead the maintenance, enhancement, and implementation of current and future solutions supporting various laboratory processes. This is a hands-on leadership role requiring technical expertise, strong management skills, and adherence to High Performance Team (HPT) standards. The position involves coordinating with business partners, securing resources, and managing consultant teams to deliver validated solutions in a GxP-compliant environment.

Major Responsibilities:

• Lead QCS lab development projects, ensuring performance meets SLAs and delivery timelines

• Develop and implement innovative solutions aligned with approved standards (SDLC, Agile, Waterfall)

• Configure lab systems (e.g., Empower DACs, AQF packages), manage IQ/OQ testing, upgrades, deployments, and data migrations

• Drive system integrations and collaboration across IT and business teams

System & Process Improvement:

• Capture customer insights and recommend continuous improvements

• Conduct fit-for-use analyses on vendor tools; manage licenses and influence vendor roadmaps

• Provide knowledge transfer to internal teams post delivery

Project Planning & Resource Management

• Coordinate resource needs with business partners; create and manage SOWs

• Identify, onboard, and manage consulting teams; monitor milestones and reconcile invoicing

• Maintain clear communication on project progress, risks, and mitigation plans

Additional Duties

• Analyze incoming demand and assess technical solutions

• Act as technical lead for QS platform design and configuration

• Ensure compliance with J&J standards and regulatory requirements

• Drive continuous improvement and resolve technical challenges to deliver business benefits.

Requirements:

• BA/BS degree required

• Minimum 2 years of experience translating business requirements into technical solutions

• Minimum of 2 years of experience working with Laboratory Information Management Systems (LIMS) such as LabVantage and/or LabWare.

• Minimum 3 years of hands-on experience with laboratory systems, including:

• • Chromatography Data System (CDS) – preferably Waters Empower

  • Scientific Data Management System (SDMS) – preferably Waters NuGenesi

  • Compliance Builder (CB) – preferably Instem/Xybion

• Experience with relational databases and scripting for data migrations required.

• Proven ability to identify, onboard, train, and manage consulting teams to deliver projects on time and within budget is required.

• Experience collaborating with business partners to align project funding and create Statements of Work (SOWs) for resource acquisition required.

• Strong knowledge of SDLC methodology, 21 CFR Part 11, GxP, CSV frameworks, and validated system highly preferred.

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