QCS Engineering Manager

Role Summary

QCS Engineering Manager for Laboratory Systems leading the maintenance, enhancement, and implementation of current and future solutions supporting laboratory processes in a GxP-compliant environment. This is a hands-on leadership role requiring technical expertise, strong management skills, and adherence to High Performance Team standards, coordinating with business partners and managing consultant teams to deliver validated solutions.

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

• 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 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
• Experience collaborating with business partners to align project funding and create Statements of Work (SOWs)
• Strong knowledge of SDLC methodology, 21 CFR Part 11, GxP, CSV frameworks, and validated system highly preferred

Skills

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