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Mid-level CQV Engineer (Lab Equipment)

amaris act pte. ltd.

Job Summary

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

This role will support the execution and coordination of qualification activities, change control, validation documentation, and equipment lifecycle compliance. The successful candidate will work closely with QC, Validation, Engineering, Quality Assurance, and external vendors to ensure laboratory equipment is qualified, documented, and maintained in accordance with site and regulatory requirements.

Your Missions

  • Support qualification activities for QC laboratory equipment in accordance with GMP, validation lifecycle, and change control requirements.

  • Coordinate and execute equipment qualification activities including IQ, OQ, and PQ where applicable.

  • Support decommissioning activities for QC laboratory equipment following approved procedures and compliance requirements.

  • Assist in defining project plans, timelines, documentation needs, and coordination activities for qualification and decommissioning projects.

  • Prepare, review, and maintain qualification protocols, reports, SOPs, risk assessments, and training materials.

  • Support deviations, investigations, CAPA, and change control activities related to laboratory equipment and qualification processes.

  • Review qualification and validation documentation to ensure completeness, traceability, and compliance with GMP and site quality expectations.

  • Collaborate with QC, Validation, Engineering, Quality Assurance, and vendors to ensure timely execution of project activities.

  • Ensure proper documentation practices, data integrity, and compliance standards are followed for laboratory equipment systems.

  • Support equipment integration activities where applicable, such as LabX connectivity or related laboratory data systems.

  • Track action items, project milestones, risks, and implementation progress to support delivery within agreed timelines.

Your Profile

  • Bachelor's degree in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, Chemistry, or a related discipline.

  • 5-8 years of experience in qualification, validation, commissioning, or lifecycle management within GMP-regulated manufacturing or laboratory environments.

  • Hands-on exposure to QC laboratory equipment qualification and validation activities.

  • Good understanding of GMP documentation, validation lifecycle, change control, deviation, and CAPA processes.

  • Experience preparing or reviewing qualification protocols, reports, SOPs, risk assessments, 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 documentation, coordination, and stakeholder communication skills.

  • Detail-oriented, organized, and comfortable working within structured quality and compliance environments.

  • Able to manage multiple tasks 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, and team buildings.

  • Strong commitments to CSR, notably through participation in our WeCare Together program.

Vacancy posted a month ago
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