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.
