Senior Engineer - DeltaV & CQV Support

·       Required to work closely with the Digital MMD teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for commissioning and qualification of DeltaV DCS.

Reporting to the Digital MMD Project Lead, specifically responsible for Automation CQV Support.

·       SME for commissioning and qualification of DeltaV system

·       Responsible for DeltaV commissioning and qualification activities, including loop testing, onsite commissioning and site testing through to OQ complete

·       Manage Automation change requests that are a product of CQV activities

·       Manage stakeholders to the DeltaV commissioning and qualification process

·       Partner with Computer System Validation (CSV) and Digital Data Quality (DDQ) teams to ensure compliance with applicable standards and policies.

·       Partner with internal Digital departments ensuring standard and secure implementation in line with MSD Standards

·       DeltaV commissioning plans and execution records.

·       Loop test documentation and completion reports.

·       Site testing and commissioning records.

·       Operational Qualification (OQ) execution evidence and reports.

·       Automation change request assessments and implementation records.

·       Validation and qualification documentation supporting CSV deliverables.

·       Risk assessments and issue resolution documentation.

·       Stakeholder and project status reports.

·       CQV completion and handover documentation.

·       Compliance and audit support records.

·       BS in Engineering, Computer Science, or other technical degree.

·       Training completed in DeltaV standard.

·       5 or more years of experience required in DeltaV application.

·       3 or more years of experience required in site-based Commissioning role in GMP environment.

·       Proven record of proficiencies associated with commissioning and qualification of complex systems on capital projects.

·       Understanding of cGMP's, SDLC methodologies and principles.

·       Excellent facilitation, problem solving, and decision-making skills.

·       Proven ability to work in cross functional teams.

·       Usual place of work will be MSD Ballydine, Ireland. This is a site-based role. The successful candidate may sometimes be required to attend meetings at Vendor premises or other MSD sites as required.

Desired

·       Spray drying experience would be advantageous.