Project Engineer

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.

Please call Louise Mulligan today for further information on 0949003979 or email: lmulligan@careerwise.ie

CareerWise Recruitment (In Search of Excellence)

Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. 

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

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