Title: CQV Project LeadLocation: County TipperaryType: 12-Month ContractSalary: DOERef: DES - 1218OverviewWe are seeking an experienced CQV API Project Lead to oversee a multi-discipline Commissioning & Qualification (C&Q) team delivering a large-scale API pharmaceutical facility project from design through to end-user handover. The successful candidate will provide leadership, technical oversight, and coordination across all C&Q lifecycle activities, ensuring safe, compliant, and high-quality delivery aligned with cGMP, ISPE, and ASTM E2500 standards.This role requires a strong background in API pharmaceutical commissioning and qualification, with proven experience leading teams in complex capital projects within regulated environments.ResponsibilitiesLead and manage the site C&Q programme across the full project lifecycle (Design through to Handover)Ensure all commissioning and qualification activities are executed in line with site procedures, cGMP, and industry best practicesOversee development and execution of C&Q protocols including IQ/OQ activitiesPlan, schedule, and coordinate vendor activities including FAT, SAT, and IOQ executionProvide technical leadership and guidance to the C&Q teamEnsure safety oversight of all C&Q activities in collaboration with the project safety teamManage change control processes throughout the project lifecycleDevelop and maintain C&Q schedules, tracking progress, forecasting, and reporting metricsProduce summary reports, status updates, and performance metrics for stakeholdersInterface with engineering, quality, client representatives, and end users across all project phasesLead and mentor C&Q team members, supporting capability development and delivery performanceForecast resource and project needs, ensuring timely interventions to meet schedule requirementsRequirementsDegree or equivalent qualification in an engineering-related discipline15+ years’ experience in commissioning and qualification within API pharmaceutical facilitiesProven experience leading and managing C&Q teams on large-scale pharma projectsStrong knowledge of ISPE guidelines and ASTM E2500 approachExperience with KNEAT and DeltaV systemsStrong leadership, communication, and stakeholder management skillsAbility to work collaboratively across multi-discipline project teams in a regulated environmentDemonstrated experience in lifecycle C&Q delivery from design through to system handover*Only candidates with a valid work visa for Ireland or an EU passport will be considered.To discuss this role in more detail, contact Corné at 0949316002 or corne@dillones.ie for a confidential discussion.
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