Pharma GMP Project Engineer – Onsite (23-Month Contract)

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

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).