Onsite GMP Project Engineer – Aseptic Systems & Compliance

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

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.