Automation Project Lead – GMP Pharma

Careerwise Recruitment

Waterford

Vor Ort

EUR 65.000 - 90.000

Vollzeit

14 Tage+
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Zusammenfassung

Careerwise Recruitment is seeking an Automation Project Engineer for a leading pharmaceutical company in Waterford. This 12-month contract leads end-to-end project execution across GMP platforms, including Lyophilizers, CLU, PMS, Autoclaves, and core control systems.

You will coordinate OEMs, ITS, Automation, Validation, and Quality teams to ensure compliant, timely delivery and execution of FAT/SAT, CQV, and change controls across the site.

Qualifikationen

  • 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.

Aufgaben

  • 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.

Kenntnisse

Project management
GMP compliance
Stakeholder communication
Change control
CQV planning

Ausbildung

Bachelor's degree in Engineering (Automation/Electrical/Chemical/Mechanical)

Jobbeschreibung

Careerwise Recruitment is seeking an Automation Project Engineer for a leading pharmaceutical company in Waterford. This 12-month contract leads end-to-end project execution across GMP platforms, including Lyophilizers, CLU, PMS, Autoclaves, and core control systems.

You will coordinate OEMs, ITS, Automation, Validation, and Quality teams to ensure compliant, timely delivery and execution of FAT/SAT, CQV, and change controls across the site.

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