Automation Project Engineer

PACIV; Cork; On-site; EUR 60,000 - 85,000; Full time

Job summary

PACIV is seeking an Automation Project Engineer in Cork, Ireland to deliver end-to-end control system upgrades and new installations. You will oversee concept studies, scheduling, stakeholder coordination, URS development, IT infrastructure readiness, and co-ordination with system integrators.

The role requires 3+ years in automation projects, strong cGMP/SDLC knowledge, and hands-on experience with Siemens Desigo BMS, PLCs/HMIs, SQL Server and OSI PI at a GMP site.

Qualifications

• BS in Engineering or equivalent technical degree.
• Computer Science or related technical degree.
• 3+ years delivering Automation Projects.
• Strong knowledge of cGMP, SDLC, LEAN/Sigma.
• Demonstrated Project Management capability.
• Ability to analyze problems, build business cases & propose solutions.
• EU Work Permit and Irish residency; no sponsorship.
• Experience with Siemens Desigo BMS, PLCs/HMIs; SQL Server; OSI PI; Thin/FAT client architecture.
• Familiarity with Fire Alarm & Access Control, 21 CFR 11, and data integrity.
• GMP manufacturing site project experience.

Responsibilities

• Deliver end-to-end automation project upgrades and new installations.
• Develop and manage project schedule and milestones.
• Coordinate stakeholders, vendors and contractors during delivery.
• Develop automation URS with System Owner.
• Scope IT infra with IT team (virtual servers, switches).
• Engage the system integrator and oversee offsite/onsite works.
• Update lifecycle docs in Kneat EDMS (FDS, RTM, QAP, QASR, FAT, SAT, IOQ).
• Act as SME for client standards in automation projects.

Skills

Project Management

GxP/ cGMP knowledge

SDLC

LEAN / Sigma

Vendor coordination

Problem solving

Decision making

Education

BS in Engineering

Computer Science or technical degree

Tools

Siemens Desigo BMS

Siemens PLCs / HMIs

SQL Server

OSI PI

Kneat (EDMS)

Thin/FAT Client architecture

Job description

Position: Automation Project Engineer. Location: Cork, Ireland.

Job Overview

The Automation Project Engineer will be responsible for end-to-end delivery of GxP and non-GxP Control System upgrades and new installations.

The Automation Project Engineer is responsible for activities that include the following:

• Concept studies and costing
• Develop and manage Project schedule
• Coordinate stakeholders, vendors and contractors during Project delivery
• Develop automation scope of works (URS) in conjunction with the System Owner
• Scope and requisition of supporting site IT infrastructure in conjunction with the IT team (Virtual Servers, IT switches etc.)
• Engage the system integrator
• Manage offsite/onsite automation works (Development, FAT testing, installation, shakedown, SAT & User Acceptance testing)
• Update/Execute/Review/approve Lifecycle documentation on Kneat Electronic Document Management System (FDS, RTM, QAP, QASR, FAT, SAT, IOQ)
• SME for client standards as they relate to Automation Projects validation, hardware, software environments and business processes.

Requirements

• BS in Engineering
• Computer Science, or other technical degree.
• 3 or more years of experience in an Automation Projects delivery role.
• Excellent understanding of cGMP's, SDLC methodologies and LEAN/MPS/ Sigma principles. Excellent facilitation, problem solving, and decision-making skills.
• Demonstrated ability in Project Management.
• Ability to analyze and define business problems, develop business cases, and identify appropriate process and technological solutions is essential
• Applicants must have a valid EU Work Permit and Irish residency, no sponsorship provided.
• Project experience with Siemens Desigo BMS (Cleanroom Environmental Control and CTU Monitoring),
• Siemens PLCs and HMIs,
• SQL Server
• OSI PI database historian
• Thin/FAT Client Application server architecture
• Fire Alarm & Access Control systems
• 21CFR11 compliance,
• Data Integrity
• Automation Project execution at a GMP manufacturing site.