Senior Engineer (DeltaV CQV Support)

Claran Consultants Ltd; Munster; On-site; EUR 90,000 - 115,000; Full time

Job summary

Claran Consultants Ltd. seeks a Senior Engineer for an 11-month contract to lead DeltaV CQV activities and support automation commissioning in a GMP environment.

The role is site-based with close collaboration to Digital MMD teams and vendors, ensuring standards and compliant documentation. Responsibilities include writing commissioning plans, conducting loop tests, executing OQ, and coordinating with CSV and DDQ teams for compliance.

Qualifications

• BS in Engineering, Computer Science, or other technical degree.
• DeltaV training completed.
• 5+ years DeltaV application experience.
• 3+ years site-based commissioning in GMP.
• Understanding of cGMPs and SDLC.
• Excellent facilitation, problem solving, and decision-making skills.
• Proven ability to work in cross functional teams.

Responsibilities

• Lead DeltaV commissioning and qualification activities from loop testing to OQ.
• Prepare commissioning plans and execution records.
• Coordinate with CSV and DDQ teams for compliance.
• Manage automation change requests from CQV activities.
• Produce validation docs, risk assessments, and status reports.
• Support CQV completion and handover.

Skills

DeltaV CQV

Commissioning

GMP

SDLC

Facilitation

Education

BS in Engineering

Computer Science

Tools

DeltaV

Job description

Job Description

A leading pharmaceutical company is seeking a Senior Engineer on an initial 11 month contract, reporting to the Digital MMD Project Lead, specifically responsible for Automation CQV Support. 5 days on site (flexibility as agreed with Manager). 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. 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. This is a site-based role. The successful candidate may sometimes be required to attend meetings at Vendor premises or other company sites as required. Desired: Spray drying experience would be advantageous. TPBN1_IJ