Project Engineer

CareerWise Recruitment; Waterford; On-site; EUR 65,000 - 90,000; Full time

Job summary

CareerWise Recruitment has partnered with a Waterford-based pharmaceutical client to recruit a Project Engineer for a 23-month, fully onsite contract. The role focuses on managing projects from scope through to validation, ensuring safety, quality, and regulatory compliance within a GMP environment.

You will coordinate with contractors and OEMs, handle procurement, prepare URS/URB, RAMS, and support regulatory inspections (FDA/EMA).

Qualifications

• Degree in Process, Mechanical, Chemical, Industrial, or equivalent Engineering discipline.
• 3–5+ years’ experience in project management; 5 years delivering engineering projects in pharmaceutical or biotech GMP environments.
• Detailed knowledge of cGMP environments with strong automation experience.
• Strong GMP/GDP regulatory compliance knowledge.
• Experience supporting FDA or EMA inspections is desirable.

Responsibilities

• 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 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.
• Attend regulatory inspections readiness and audit preparation activities (FDA, EMA).

Skills

Project management

GMP awareness

Regulatory compliance

Aseptic processing

Documentation control

Education

Engineering degree

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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