QCS Engineering Manager

QCS Engineering Manager at Johnson & Johnson

Locations:
Skillman, Raritan NJ;
Titusville NJ;
Malvern PA;
Springhouse PA;
Milpitas CA;
Tampa FL.

We are seeking a QCS Engineering Manager, located at one of the sites listed above. 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.

• 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.

• BA/BS degree required
• Minimum 2 years of experience translating business requirements into technical solutions
• Minimum 2 years of experience working with Laboratory Information Management Systems (LIMS) such as Lab Vantage and/or Lab Ware.
• 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 Nu Genesi
• 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.
• Experience collaborating with business partners to align project funding and create Statements of Work (SOWs) for resource acquisition.
• Strong knowledge of SDLC methodology, 21 CFR Part 11, GxP, CSV frameworks, and validated system highly preferred.

• 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

• Base: $ – $
• Bay Area: $ – $

• Vacation – 120 hours per calendar year
• Sick time – 40 hours per calendar year (48 hours for Colorado residents; 56 hours for Washington residents)
• 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 period (10 days)
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time‑Off – 80 hours per calendar year

Johnson &…