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CQV Engineer (Lab Equipment)

amaris act pte. ltd.

Job Summary

We are looking for a QC Equipment Qualification to support qualification, lifecycle management, and decommissioning activities for Quality Control (QC) laboratory equipment within a GMP-regulated medical manufacturing environment.

This role will be responsible for managing qualification activities, supporting change control and validation processes, and ensuring equipment compliance throughout the equipment lifecycle. The successful candidate will work closely with Quality, Validation, Engineering, and Laboratory teams to support operational readiness, documentation compliance, and project execution for laboratory equipment systems.

Your missions

  • Manage qualification activities for QC laboratory equipment in accordance with GMP validation and change control processes
  • Support and manage decommissioning activities for QC equipment following approved procedures and compliance requirements
  • Define project strategies, implementation plans, timelines, and coordination activities for qualification and decommissioning projects
  • Coordinate qualification lifecycle activities including installation, operational, and performance qualification (IQ/OQ/PQ) where applicable
  • Support deviations, investigations, CAPA, and change control activities related to laboratory equipment and qualification processes
  • Author and maintain SOPs, qualification protocols, reports, risk assessments, and training materials
  • Review qualification and validation documentation to ensure compliance with GMP and site quality requirements
  • Collaborate closely with QC, Validation, Engineering, Quality Assurance, and external vendors to ensure timely project execution
  • Ensure proper documentation, traceability, and data integrity practices for laboratory equipment systems
  • Support equipment integration activities where applicable (e.g., LabX connectivity and laboratory data systems)
  • Track project milestones, risks, action items, and implementation progress to ensure delivery within timelines

Your profile

  • Bachelor's degree in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, Chemistry, or related disciplines
  • Minimum 2-3 years of experience in supporting qualification, validation, commissioning, or lifecycle management activities within GMP-regulated manufacturing environments
  • Exposure to QC laboratory equipment qualification and validation processes
  • Understanding of GMP documentation, validation lifecycle, change control, deviation, and CAPA processes
  • Experience authoring qualification protocols, reports, SOPs, or validation documentation
  • Familiarity with analytical or laboratory equipment such as continuous flow analysers, nitrogen analysers, TOC systems, gas generators, analytical balances, microbalances, or similar laboratory instrumentation would be an advantage
  • Exposure to laboratory system integration platforms such as LabX or related laboratory software systems is preferred
  • Strong coordination, documentation, and stakeholder management skills
  • Detail-oriented with the ability to work within structured quality and compliance environments
  • Able to manage multiple activities and timelines within project-based environments

What we offer

  • An international community, bringing together 110+ different nationalities
  • An environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibilities
  • A robust training system with our internal Academy and 250+ available modules
  • A vibrant workplace that frequently gathers for internal events (afterworks, team buildings, etc.)
  • Strong commitments to CSR, notably through participation in our WeCare Together program
Vacancy posted a month ago
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