Junior Project Engineer - Production Equipment

Wallace Myers International

Waterford

On-site

EUR 42,000 - 54,000

Full time

3 days ago
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Job summary

Wallace Myers International currently seeks a Junior Project Engineer to support production equipment projects at a major biopharma client site in Waterford. The role focuses on supporting a diverse project portfolio from conception to completion within GMP environments.

Ideal candidates have 2–3 years post-graduation experience, initiative, and the ability to work with senior engineers. The position involves schedule, cost, quality, safety, and regulatory adherence across multi‑million‑euro

Qualifications

  • 2–3 years’ experience supporting engineering projects in pharma/biotech GMP environments.
  • Detailed knowledge of cGMP environments is required.
  • Strong understanding of GMP/GDP requirements and regulatory compliance frameworks.

Responsibilities

  • Support all elements of assigned projects including schedule, cost, scope, safety, quality, and regulatory compliance.
  • Support design management and ensure compliance with scope, user requirements, and GMP/GDP standards.
  • Attend project meetings, ensuring accurate documentation and timely action.
  • Coordinate with Document Control for timely submission of project documentation.
  • Work within a team across multiple phased projects.
  • Perform procurement activities, equipment acceptance, and infrastructure delivery, reporting regularly on project status.
  • Ensure compliance with environmental, health, and safety codes, KPIs, and specifications.
  • Liaise with internal and external stakeholders, suppliers, and vendors for right‑first‑time project delivery.
  • Provide weekly progress reports to management and senior stakeholders.
  • Review engineering deliverables, initiate change controls, and manage documentation throughout the lifecycle.

Skills

GMP experience
Regulatory compliance
Project coordination

Education

Bachelor/Master in Process, Mechanical, Chemical, Industrial Engineering

Tools

MS Office
Project management software

Job description

Contract

Waterford

Jenn Dinan at Wallace Myers is recruiting a Junior Project Engineer -Production equipment to work on contract at our Global Biopharma client's site in Waterford.

About the Opportunity

We are seeking an Equipment Project Engineer to support a diverse project portfolio within a biopharmaceutical manufacturing environment. The role involves supporting operations across enzyme, monoclonal antibodies (mAbs), medical device, laboratory, and packaging areas.

We are seeking a candidate of a more junior level. Our team requires the person who can assist our more senior established team. We are seeking someone who has initiative, will learn and is a self-starter

~ 2 to 3 years post-graduation.

The successful candidate will support all project activities to ensure adherence to schedule, cost, quality, safety, and scope from conception to completion. Assigned projects will form part of a multi‑million‑euro capital portfolio.

Key Responsibilities

  • Support all elements of assigned projects including schedule, cost, scope, safety, quality, and regulatory compliance.
  • Support design management and ensure compliance with scope, user requirements, and GMP/GDP standards.
  • Attend project meetings, ensuring accurate documentation and timely action
  • Coordinate with Document Control for timely submission of project documentation.
  • Work within a team environment across multiple phased projects.
  • Perform procurement activities, equipment acceptance, and infrastructure delivery, reporting regularly on project status throughout the lifecycle.
  • Ensure compliance with environmental, health, and safety codes, approved KPIs, performance standards, and specifications.
  • Liaise with internal and external stakeholders, suppliers, and vendors to ensure right‑first‑time project delivery.
  • Provide weekly progress reports to management and senior stakeholders.
  • Support project participants in resolving obstacles as they arise.
  • Review engineering deliverables, initiate change controls, and manage documentation required throughout the project lifecycle.

Quality & Regulatory Compliance

  • Ensure full compliance with GMP, GDP, and Change Control processes.
  • Ensure cleanroom construction activities maintain required environmental classifications.
  • Support risk assessments for GMP‑impact areas including cleaning validation, environmental monitoring, and sterility assurance.
  • Coordinate with Quality Assurance for deviation management and CAPA implementation.
  • Ensure proper documentation control for validation deliverables, protocols, and reports.
  • Support regulatory inspection readiness and audit preparation activities (FDA, EMA).
  • Maintain documentation control systems for submittals, RFIs, specifications, and qualification records.
  • Ensure documentation reviews are completed by all stakeholders and filed per project deliverables.
  • Engage with key departments to ensure successful and compliant project outcomes.

Technical Skills

  • Develop solutions with vendors, OEMs, and end users.
  • Experience with production equipment, qualification, and GMP facility upgrades.
  • Good understanding of aseptic processing, contamination control strategies, and cleanroom design principles.
  • Familiarity with cleanroom classification standards (ISO 14644, EU GMP Grades A-D).
  • Understanding of qualification and validation lifecycle including CSV, equipment qualification, and cleaning validation.
  • Understanding of HVAC systems, pressure cascades, and environmental monitoring requirements.
  • Working knowledge of PSCS responsibilities.
  • Proficiency in MS Office and project management software.

About You - Essential Requirements

  • Degree in Process, Mechanical, Chemical, Industrial, or equivalent Engineering discipline.
  • 2-3 years' experience supporting engineering projects in pharmaceutical or biotech GMP environments.
  • Detailed knowledge of cGMP environments
  • Strong understanding of GMP/GDP requirements and regulatory compliance frameworks.
  • Master's degree is an advantage.

All applications will be treated with the strictest of confidence.

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