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Our client, a leading pharmaceutical company in Tipperary, is seeking a DeltaV CQV Engineer to support DeltaV commissioning, qualification and validation activities for a major capital project. The successful candidate will act as a DeltaV subject matter expert and collaborate with Automation, IT, validation, quality and vendor teams through to Operational Qualification and handover.
Responsibilities include planning and executing loop testing, site commissioning, and compiling commissioning
Summary: Our client, a leading pharmaceutical company in Tipperary, is seeking a DeltaV CQV Engineer to support DeltaV commissioning, qualification and validation activities for a major capital project. The successful candidate will act as a DeltaV subject matter expert and collaborate with Automation, IT, validation, quality and vendor teams through to Operational Qualification and handover. Responsibilities: Collaborate with Automation, IT and vendor teams across the DeltaV commissioning and qualification scope. Act as the subject matter expert for DeltaV commissioning and qualification activities. Plan and execute loop testing, site commissioning and testing through to Operational Qualification completion. Prepare commissioning plans, execution records, test documentation, evidence and completion reports. Assess, manage and document Automation change requests arising from CQV activities. Partner with Computer System Validation and data quality teams to meet applicable procedures, standards and policies. Support secure, standardised Automation system implementation in line with site and regulatory requirements. Prepare validation and qualification documentation supporting Computer System Validation deliverables. Complete risk assessments and document technical issues, resolutions and corrective actions. Manage stakeholders and provide clear project progress, issue and status reporting. Prepare CQV handover documentation and provide compliance and audit support. Qualifications & Experience: Degree in Engineering, Computer Science or another relevant technical discipline. Formal training in DeltaV standards and system applications. Minimum of five years DeltaV application experience. Minimum of three years site-based commissioning experience within a GMP-regulated environment. Proven experience commissioning and qualifying complex systems on capital projects. Strong understanding of current Good Manufacturing Practice requirements and System Development Life Cycle principles. Experience preparing and executing CQV documentation. Spray drying experience would be advantageous. TPBN1_IJ