Project Engineer

CareerWise Recruitment; Waterford; On-site; EUR 65,000 - 85,000; Full time

Job summary

CareerWise Recruitment is seeking a Project Engineer for a 23-month contract with a Waterford pharmaceutical client. This fully onsite role requires experience with production equipment, qualification activities, and GMP facility upgrades.

You will manage projects from inception through delivery, coordinate with QA and suppliers, and ensure adherence to GMP and ISO 14644 cleanroom standards. The role emphasizes documentation, change control, and regulatory readiness.

Qualifications

• 3–5+ years in project management in pharma/GMP environments.
• Experience delivering engineering projects in pharmaceutical or biotech GMP environments.
• Detailed knowledge of cGMP environments with strong automation experience.
• Experience supporting FDA or EMA inspections is desirable.

Responsibilities

• Manage all elements of assigned projects including schedule, cost, scope, safety, quality, and regulatory compliance.
• Oversee contractor and OEM performance to meet quality, schedule, safety and GMP expectations.
• Perform procurement activities, equipment acceptance and infrastructure delivery, reporting progress throughout lifecycle.
• Ensure compliance with environmental, health, and safety codes, approved KPIs and specifications.
• Identify and communicate delays through formal change control processes.
• Develop and maintain URS/URB documentation.
• Ensure RAMS are prepared and implemented before works commence.
• Ensure cleanroom construction maintains required environmental classifications.
• Support risk assessments for GMP impact areas including cleaning validation and environmental monitoring.
• Coordinate with QA for deviation management and CAPA implementation.
• Ensure 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.
• Attend FATs and draft/review protocols and reports.

Skills

Project management

Regulatory compliance

GMP knowledge

Risk assessment

Education

Engineering degree (Process/Mechanical/Chemical/Industrial)

Job description

A Project Engineer is required by CareerWise Recruitment for a 23-month contract position with our Waterford based pharmaceutical client. This is a fully onsite position. If you are coming from a strong ascetic environment and you have experience in production equipment, qualification, and GMP facility upgrades then this is the position for you !!!

THE ROLE

• Manage all elements of assigned projects including schedule, cost, scope, safety, quality, and regulatory compliance.
• Manage contractor and OEM performance to ensure compliance with quality, schedule, safety, and GMP expectations.
• 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.
• Identify, record, and communicate delays through formal change control processes.
• Develop and maintain URS/URB documentation.
• Ensure all works are planned and executed safely under Safe Systems of Work.
• Ensure RAMS are prepared and implemented before works commence.
• 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.
• Attend FATs and draft/review protocols and reports.
• 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.

REQUIREMENTS

• Degree in Process, Mechanical, Chemical, Industrial, or equivalent Engineering discipline.
• Minimum 3- 5+ years’ experience in project management; 5 year’s 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.

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