QCS Engineering Manager

Johnson & Johnson•Raritan, NJ

52d•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 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.

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.

Nice To Haves

Laboratory Information Management System (LIMS)
Relational Database
Technical Solutions
Collaborating
Compliance Management
Corrective and Preventive Action (CAPA)
Data Quality
Data Savvy
Developing Others
Incident Management
Inclusive Leadership
Leadership
Operations Management
Performance Measurement
Quality Control (QC)
Quality Management Systems (QMS)
Quality Services
Quality Standards
Risk Management
System Integration
Systems Analysis
Tactical Planning
Team Management

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
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
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
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.

Benefits

employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
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