QCS Engineering Manager

Role Summary

QCS Engineering Manager for Laboratory Systems leads the maintenance, enhancement, and implementation of current and future solutions supporting various laboratory processes. This hands-on leadership role requires 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. Location can be Skillman, Raritan NJ, Titusville NJ, Malvern PA, Springhouse PA, Milpitas CA, or Tampa FL.

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

Qualifications

• Required: BA/BS degree
• Required: Minimum 2 years of experience translating business requirements into technical solutions
• Required: Minimum 2 years of experience with Laboratory Information Management Systems (LIMS) such as LabVantage and/or LabWare
• Required: 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
• Required: 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
• 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 systems

Skills

• Laboratory Information Management System (LIMS)
• Relational Database
• Technical Solutions

Education

• BA/BS degree required