Senior CQV Engineer (Lab Equipment)

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Job Summary We are looking for a Senior QC Equipment Qualification Specialist / Lead to manage qualification, lifecycle management, and decommissioning activities for Quality Control laboratory equipment within a GMP-regulated manufacturing environment. This role will take ownership of qualification strategy, project execution, documentation compliance, risk management, and stakeholder coordination across laboratory equipment lifecycle activities. The successful candidate will act as a senior technical contributor and coordination lead, working closely with QC, Validation, Engineering, Quality Assurance, and external vendors to ensure equipment systems remain compliant, audit-ready, and aligned with site and regulatory expectations. Your Missions Lead qualification activities for QC laboratory equipment in accordance with GMP, validation lifecycle, and site change control requirements. Own and manage equipment qualification lifecycle activities including IQ, OQ, PQ, requalification, periodic review, and decommissioning where applicable. Define project strategies, implementation plans, timelines, risk mitigation approaches, and resource coordination for qualification and decommissioning projects. Lead decommissioning activities for QC laboratory equipment in accordance with approved procedures, compliance requirements, and site quality standards. Author, review, and approve qualification protocols, reports, SOPs, risk assessments, traceability matrices, and training materials. Provide technical guidance on deviations, investigations, CAPA, change control, and impact assessments related to laboratory equipment and qualification processes. Review validation and qualification documentation to ensure compliance with GMP, GDP, data integrity, and regulatory expectations. Partner closely with QC, Validation, Engineering, Quality Assurance, IT, and external vendors to drive timely and compliant project execution. Ensure documentation traceability, inspection readiness, and lifecycle compliance for laboratory equipment systems. Support and coordinate laboratory equipment integration activities where applicable, including LabX connectivity or related laboratory data systems. Monitor project milestones, risks, dependencies, action items, and implementation progress to ensure delivery within timelines. Act as a subject matter expert for QC laboratory equipment qualification, lifecycle management, and compliance-related discussions. Your Profile Bachelor's degree in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, Chemistry, or a related discipline. 10+ years of experience in equipment qualification, validation, commissioning, lifecycle management, or compliance within GMP-regulated manufacturing or laboratory environments. Strong experience managing QC laboratory equipment qualification and validation activities. Solid understanding of GMP, GDP, data integrity, validation lifecycle, change control, deviation, CAPA, risk assessment, and audit readiness requirements. Proven experience authoring, reviewing, and leading qualification protocols, reports, SOPs, risk assessments, validation plans, and related compliance documentation. Experience managing qualification or decommissioning projects involving multiple stakeholders, vendors, and timelines. 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. Experience with laboratory system integration platforms such as LabX or related laboratory software systems is preferred. Strong stakeholder management, project coordination, documentation review, and technical problem-solving skills. Able to work independently, guide project teams, and manage competing priorities in a structured GMP environment. Detail-oriented, compliance-focused, and capable of supporting inspection or audit readiness activities.

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Company Intel

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