Equipment Project Engineer - Production Equipment

Contract

Waterford

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

Equipment Project Engineer - Production Equipment (Ltd Contract Role)

Job Title: Equipment Project Engineer

About the Opportunity

We are seeking an experienced Equipment Project Engineer to deliver 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. The successful candidate will schedule, plan, forecast, resource, and manage 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

• Manage all elements of assigned projects including schedule, cost, scope, safety, quality, and regulatory compliance.
• Lead design management and ensure compliance with scope, user requirements, and GMP/GDP standards.
• Lead and attend project meetings, ensuring accurate documentation and timely action closure.
• Manage contractor and OEM performance to ensure compliance with quality, schedule, safety, and GMP expectations.
• 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.
• Assign responsibilities, mentor project team members, and maintain accurate project planning documentation in line with project governance requirements.
• 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.
• Deliver performance metrics for budget, schedule, scope, and quality adherence.

Schedule Management Scope & Cost Management Quality & Regulatory Compliance Validation & Qualification Coordination

• Coordinate with CQV teams for equipment and facility qualification activities.
• Attend FATs and draft/review protocols and reports.

Project Management Skills

• Strong background in project planning, scheduling, budgeting, and risk management.
• Ability to manage complex multi?stakeholder projects within a regulated environment.

Technical Skills

• Develop solutions with vendors, OEMs, and end users.
• Experience with production equipment, qualification, and GMP facility upgrades.
• Strong 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.
• Minimum 5 years' experience in project management; 5-10 years' experience delivering engineering projects in pharmaceutical or biotech GMP environments.
• Detailed knowledge of cGMP environments with strong automation experience.
• Strong understanding of GMP/GDP requirements and regulatory compliance frameworks.
• Experience supporting FDA or EMA inspections is desirable.
• Master's degree is an advantage.

All applications will be treated with the strictest of confidence.
These are professional service contracts (Hourly rate Ltd contract )

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