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Hire.Monster

QCS Engineering Manager

Company
Spring House, Pennsylvania, US
ОфисМенеджмент$$102k - $$177k

Обязанности

  • 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
  • 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
  • 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

Требования

  • 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

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

Навыки

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

Условия

$118,000.00 - $203,550.00

  • Subject to the terms of their respective plans, 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

Зарплата

$102'000 - $177'100

Опубликовано: 13.01.2026