CQV Engineer

PE Global (UK); Munster; On-site; EUR 85,000 - 110,000; Full time

Job summary

PE Global is recruiting for a DeltaV CQV Support Senior Engineer for our pharmaceutical client in Tipperary, Ireland. This is an initial 12-month contract, onsite role.

Reporting to the Digital MMD Project Lead, you will support DeltaV commissioning and qualification activities, collaborating with CSV and DDQ teams to ensure cGMP compliance. Hours are 40 per week with 5 days on site and an immediate start.

Qualifications

• BS in Engineering, CS, or technical degree.
• DeltaV standard training completed.
• 5+ years in DeltaV application.
• 3+ years on-site Commissioning in GMP.
• Proven commissioning/qualification of complex systems on capital projects.
• Understanding of cGMP, SDLC methodologies.
• Excellent facilitation, problem solving, and decision-making.
• Able to work in cross-functional teams.
• Site-based role; may attend vendor meetings.

Responsibilities

• Work with Digital MMD teams on Automation and IT scope for DeltaV CQV.
• Serve as SME for DeltaV commissioning and qualification.
• Carry out DeltaV commissioning/qualification activities including loop testing and OQ completion.
• Manage Automation change requests from CQV activities.
• Engage with CSV and DDQ teams to ensure compliance with standards.
• Coordinate with internal Digital groups to ensure secure, standard implementation.

Skills

DeltaV CQV expertise

GMP experience

Stakeholder management

Cross-functional collaboration

Problem solving

Education

BS in Engineering/Computer Science or technical degree

Tools

DeltaV automation software

Job description

PE Global is recruiting for a DeltaV CQV Support Senior Engineer for our pharmaceutical client in Tipperary. This is an initial 12-month contract, onsite role.

Engagement Summary

1. Objective: Reporting to the Digital MMD Project Lead, specifically responsible for Automation CQV Support.
2. Engagement Type: Time-and-materials
3. Location/Mode: 5 days on site (flexibility as agreed with Manager)
4. Start Date: Immediate
5. Duration: Q1 (2028) approx.
6. Hours/Shift: 40 hours per week

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 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 sites as required.

Desired:

• Spray drying experience would be advantageous.

Onboarding Checklist (Resource + DMMD)

• DMMD: Approve and submit access requests for Kneat Gx/eVal, MEDS (Coordinator access), SharePoint sites, and PIMS. Provide expected provisioning timeframe and contact owner.
• DMMD: Provide list of required compliance checks (right-to-work, background/security checks) and initiate as required.
• Resource: Confirm receipt of start details, first-day schedule, and reporting line. Acknowledge compliance requirements.

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***