Senior Engineer – DeltaV CQV Support

Ref. 1407

Senior Engineer – DeltaV CQV Support

Asset Recruitment is currently seeking a Senior Engineer – DeltaV CQV Support on behalf of our client, a leading global pharmaceutical company.
Reporting to the Digital MMD Project Lead, the successful candidate will be responsible for Automation CQV Support, with a specific focus on the commissioning and qualification of DeltaV DCS.

Responsibilities:
·       Act as the Subject Matter Expert (SME) for commissioning and qualification of the 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 the company’s 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:
·       BS in Engineering, Computer Science, or other technical degree.

·       Completed training in DeltaV standards.

·       5+ years’ experience required in DeltaV application.

·       3+ years’ experience required in site-based Commissioning role in GMP environment.

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

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

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

·       Proven ability to work in cross functional teams.

·       Spray drying experience would be advantageous.

Notes:
Usual place of work will be Ballydine, Co. Tipperary, Ireland. The role may occasionally be required to attend meetings at vendor premises or other company sites as required.