QCS Engineering Manager

Role Summary

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.

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

Responsibilities

• 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

Responsibilities

• 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

Responsibilities

• 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 of 2 years of experience working 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 system highly preferred

Skills

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

Preferred Skills

• Collaborating, Compliance Management, CAPA, Data Quality, Data Savvy, Developing Others, Incident Management, Inclusive Leadership, Leadership, Operations Management, Performance Measurement, QC, QMS, Quality Services, Quality Standards, Risk Management, System Integration, Systems Analysis, Tactical Planning, Team Management