Project Engineer

EFOR; Westport; On-site; EUR 75,000 - 120,000; Full time

Job summary

EFOR in Westport, Ireland is seeking a Project Engineer with a strong background in aseptic manufacturing to lead engineering projects in pharmaceutical or food production environments.

The role focuses on designing, implementing, and optimizing aseptic processing systems, managing capital projects, and ensuring compliance with GMP, FDA, EU Annex 1, and other regulatory standards while coordinating with QA, Manufacturing, and Validation teams.

Qualifications

• Bachelor’s degree in Engineering; Master’s degree preferred.
• 5+ years of hands-on project engineering in aseptic manufacturing.
• Experience managing capital projects in regulated environments.
• Knowledge of GMP, FDA, EU Annex 1 and related standards.

Responsibilities

• Lead and coordinate engineering projects from concept through completion.
• Oversee installation and commissioning of aseptic equipment and cleanroom systems.
• Develop project schedules, budgets, and resources.
• Ensure designs comply with GMP, FDA, EU Annex 1 and other regulatory standards; perform risk assessments.
• Provide technical expertise in aseptic facility design and production flows.

Skills

Project management

Aseptic manufacturing knowledge

GMP/FDA knowledge

Regulatory compliance

Education

Bachelor’s degree in Engineering

Master’s degree preferred

Tools

MS Project

CAD software

Job description

Position Overview:

We are seeking a highly skilled Project Engineer with a strong background in aseptic manufacturing to join our team. The successful candidate will have more than 5 years of experience leading and executing engineering projects in pharmaceutical or food production environments. This role will focus on designing, implementing, and optimizing aseptic processing systems and ensuring regulatory compliance.

Key Responsibilities:

• Lead and coordinate engineering projects related to aseptic manufacturing, from concept through completion
• Oversee installation and commissioning of aseptic processing equipment and cleanroom systems
• Collaborate with cross-functional teams, including QA, Manufacturing, and Validation to ensure project alignment and success
• Develop and manage project schedules, budgets, and resources
• Prepare engineering documentation: project plans, commissioning reports, validation protocols, SOPs, and risk assessments
• Ensure designs and implementations comply with GMP, FDA, and other relevant regulatory standards
• Support troubleshooting and continuous improvement initiatives for aseptic processes and equipment
• Conduct technical reviews of equipment specifications, P&IDs, and layouts
• Manage vendor relationships and oversee contractor work on site
• Provide technical expertise in aseptic facility design, layout, and production flows

Qualifications:

• Bachelor’s degree in Engineering (Chemical, Mechanical, Industrial, or related field); Master’s degree preferred
• Minimum of 5 years’ hands-on project engineering experience in aseptic manufacturing (pharmaceutical, biotech, or food)
• Demonstrated success in managing capital projects in regulated environments
• In-depth knowledge of aseptic technologies, cleanroom requirements, and contamination control principles
• Familiarity with industry standards and regulations (GMP, FDA, EU Annex 1, etc.)
• Strong problem-solving, organizational, and communication skills
• Ability to work collaboratively and independently
• Proficient in engineering software, project management tools, and Microsoft Office Suite