Scope and Core Responsibilities

· 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

Deliverables

· 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.

Requirements

Required Qualifications and Competencies

· 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.

Senior Engineer - DeltaV & CQV Support