Equipment Project Engineer – Production Equipment

Role Summary:

• We are seeking an experienced Equipment Project Engineer to deliver a diverse project portfolio within a biopharmaceutical manufacturing environment based on site in Co. Waterford.
• 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.

Core Duties and 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

• Identify, record, and communicate delays through formal change control processes.
• Lead schedule workshops and proactively challenge contractors to maintain milestones.

Scope & Cost Management

• 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.

Safety

• 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.

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.

Validation & Qualification Coordination

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

Resources

• Monitor progress against plan and escalate resource constraints as required.

Minimum Qualifications and 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.
• Proven ability to lead cross‑functional teams and coordinate contractors in a GMP setting.
• Strong analytical, problem‑solving, and decision‑making capabilities.
• 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.

Please note, we do not require agency assistance with this role.