DeltaV CQV Engineer

Tandem Project Management Ltd.; Tipperary; On-site; EUR 85,000 - 110,000; Full time

Job summary

Tandem Project Management Ltd. is seeking a DeltaV CQV Engineer for a leading pharmaceutical project in Tipperary.

The role focuses on DeltaV commissioning, qualification and validation activities across a major capital project, acting as a DeltaV SME and coordinating with Automation, IT, validation, quality and vendor teams through to OQ and handover. The ideal candidate holds a degree in engineering or computer science, has formal DeltaV training, and at least five years of DeltaV experience

Qualifications

• 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 SDLC principles.
• Experience preparing and executing CQV documentation.
• Spray drying experience would be advantageous.

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.

Skills

DeltaV expertise

CQV documentation

GMP knowledge

Education

Bachelor's degree in Engineering, Computer Science or similar

Job description

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.