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.

·       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.