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Csv labs engineer

Cork
Milestone
Engineer
Posted: 22 January
Offer description

Company DescriptionMilestone, a division of the global PM Group, provides advanced automation and digital systems consultancy services, specializing in Life Sciences and FMCG sectors. With a team of over 160 experts, we bring a comprehensive perspective to project implementation through our experience as end users, engineering consultants, and system integrators. Our service offerings include digital factory delivery, system integration, compliance, and manufacturing intelligence among others, ensuring tailored solutions for business needs. As part of the employee-owned PM Group, which operates in Europe, the UK, USA, and Asia, Milestone combines decades of expertise with a commitment to optimizing client outcomes.Key ResponsibilitiesExecute Computer System Validation (CSV) activities for laboratory analytical instruments in compliance with the AIQ process, site procedures, and global standards.Manage validation of a diverse instrument portfolio, including new, in-use, unqualified, and previously qualified systems .Author, review, and approve AIQ lifecycle documentation, including: User/Regulatory Requirements, Configuration Specifications, Risk Assessments, IQ/OQ protocols and reports, Traceability Matrices, Validation Summary ReportsExecute and support IQ/OQ testing, including protocol execution, deviation management, and variance resolution.Verify instrument configuration, data integrity controls, audit trails, and security settings in line with GMP and data integrity expectations .Interface with LabVantage, Empower, and other enterprise systems to support instrument connectivity and data flow validation.Collaborate closely with Quality, Automation/IT, and laboratory stakeholders to ensure consistent application of standards.Support coordination and technical oversight of onsite contractors, ensuring consistent execution of CSV activities.Maintain validation schedules, trackers, and metrics, ensuring all CSV deliverables are completed within project timelines.Participate in risk assessments and impact analyses, supporting mitigation strategies to protect schedule and compliance.Drive efficiencies by leveraging standardized AIQ templates and governed approaches to reduce validation effort, cost, and cycle time.Ensure validation documentation is complete, accurate, and inspection-ready .Qualifications & ExperienceBachelor's degree in Engineering, Computer Science, or a related technical discipline.3–5+ years' experience in CSV, Automation, IT, or laboratory systems validation within a regulated environment.Hands-on experience with laboratory analytical instrument qualification and system implementation.Strong understanding of AIQ, CSV lifecycle, and data integrity principles .Experience with enterprise laboratory systems such as LabVantage, Empower, or similar.Proven ability to manage multiple priorities and deliver against aggressive timelines.Excellent communication, facilitation, problem-solving, and collaboration skills.

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