Automation Project Engineer

CareerWise Recruitment

Waterford

On-site

EUR 90,000 - 120,000

Full time

11 hours ago
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Job summary

CareerWise Recruitment is seeking an Automation Project Engineer for a leading pharmaceutical company in Waterford on a 12-month contracting basis. You will lead end-to-end project execution across GMP platforms, coordinating OEMs, ITS, Automation, Validation, and Quality teams to deliver compliant upgrades.

The role covers FAT/SAT, CQV, and documentation while managing timelines and budgets to ensure milestones are met.

Qualifications

  • Bachelor’s degree in Engineering (Automation, Electrical, Chemical, Mechanical, or related field).
  • 3–5 years in equipment and automation project delivery in regulated pharma/biotech GMP.
  • Experience with server/control system upgrades and major process equipment.
  • Proven ability to lead cross-functional OEM, ITS, Automation, QA, and Validation teams.

Responsibilities

  • Manage full project lifecycles for complex automation and process equipment upgrades from concept to operational handover.
  • Oversee deployment and upgrading of equipment servers, control system platforms, and field instrumentation.
  • Lead FAT, SAT, Commissioning, CQV activities.
  • Act as liaison between OEMs, ITS, Automation, Quality Assurance, and Validation stakeholders.
  • Author and execute change controls, documentation, and risk assessments per GMP, GDP, safety, and regulatory standards.
  • Manage timelines, resources, vendor deliverables, and budgets to meet milestones.

Skills

Project management
Automation engineering
GMP compliance
Stakeholder communication
Documentation

Education

Bachelor’s degree in Engineering

Tools

FAT execution
CQV

Job description

An Automation Project Engineer is required for a leading pharmaceutical Company based in Waterford. This is a 12-month contracting position. You will lead end-to-end project execution across high-impact GMP platforms, including Lyophilizers (Lyo), Component Preparation & Washing (CLU), Particle Monitoring Systems (PMS), Autoclaves, and core control systems. You will serve as the central project lead, aligning Original Equipment Manufacturers (OEMs), Information Technology & Systems (ITS), Automation, Validation, and Quality teams to ensure seamless, compliant delivery.

Key Responsibilities
  • Manage full project lifecycles for complex automation and process equipment upgrades from concept to operational handover.
  • Oversee the deployment and upgrading of equipment servers, control system platforms, and field instrumentation.
  • Lead Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Commissioning, Qualification, and Validation (CQV) activities.
  • Act as the key liaison between OEMs, internal ITS, Automation, Quality Assurance, and Validation stakeholders.
  • Author and execute change controls, technical documentation, and risk assessments while maintaining strict adherence to GMP, GDP, safety, and regulatory standards.
  • Manage project timelines, resource allocation, vendor deliverables, and budgets to ensure milestones are met on schedule.
Qualifications & Experience
  • Bachelor’s degree in Engineering (Automation, Electrical, Chemical, Mechanical, or related field).
  • 3-5 years of hands-on equipment and automation project delivery within a regulated Pharmaceutical or Biotech GMP manufacturing environment.
  • Proven track record with server/control system upgrades and major process equipment (e.g., Lyophilizer units, Autoclaves, CLU, or PMS systems).
  • Strong expertise in directing OEM vendors, managing FAT/SAT execution, and navigating site change control processes.
  • Demonstrated skills in schedule management, budget control, and multi-stakeholder communication.
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