Senior Engineer - DeltaV & CQV Support

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.