Junior Project Engineer - Production Equipment

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.