Equipment Project Engineer - Production Equipment TPM6086

Summary:

Our client, a biopharma company based in Waterford is seekingan 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.

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.
• 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.
• Review engineering deliverables, initiate change controls, and manage documentation required throughout the project lifecycle.
• Deliver performance metrics for budget, schedule, scope, and quality adherence.
• Identify, record, and communicate delays through formal change control processes.
• Lead schedule workshops and proactively challenge contractors to maintain milestones.
• Develop and maintain URS/URB documentation.
• Control scope and cost changes through formal change processes.
• Align budget and schedule with scope requirements and prevent scope creep.
• Ensure all works are planned and executed safely under Safe Systems of Work.
• Ensure RAMS are prepared and implemented before works commence.
• Support Construction Management and Area Management teams to ensure safe execution within GMP-controlled environments.
• 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.
• Coordinate with CQV teams for equipment and facility qualification activities.
• Attend FATs and draft/review protocols and reports.
• Monitor progress against plan and escalay resource constraints as required.

Qualifications & Experience:

• Degree in Process, Mechanical, Chemical, Industrial, or equivalent Engineering discipline.
• Master's degree is an advantage.
• 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.
• Strong background in project planning, scheduling, budgeting, and risk management.
• Ability to manage complex multi-stakeholder projects within a regulated environment.
• 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.