Project Engineer

R Dpartners; Munster; On-site; EUR 55,000 - 69,000; Full time

Job summary

R&D Partners is seeking a Project Engineer to join a leading pharmaceutical company in ROI, Ireland. This fully onsite contract role focuses on manufacturing and engineering operations, supporting product development, optimizing processes, and ensuring cGMP compliance.

Responsibilities include developing and optimizing industrial processes from scale-up to commercial production, performing root cause analysis, coordinating with QA/QM/Operations, and overseeing equipment qualification,

Qualifications

• Strong background in manufacturing and engineering within the pharmaceutical industry.
• Expertise in cGMP compliance and GDP compliance.
• Experience with equipment qualification, validation, and lifecycle management.
• Proficiency in root cause analysis and process optimization.
• Excellent communication and coordination skills.
• Ability to manage multiple projects and meet deadlines.

Responsibilities

• Support product development and launch campaigns.
• Develop and optimize industrial processes from scale-up to commercial production.
• Perform root cause analysis of manufacturing issues.
• Ensure engineering qualification and validation records comply with cGMP, GDP requirements, and SOPs.
• Prepare, review, and update study outlines, protocols, and SOPs to meet cGMP requirements.
• Coordinate with design consultants and user departments for process-manufacturing equipment design.
• Review and approve detailed designs submitted by vendors.
• Manage project execution across QA, QM, and Operations to meet deadlines.
• Conduct FAT-SAT activities for newly installed equipment/systems.
• Oversee installation and operational qualification activities for process-manufacturing equipment.
• Develop lifecycle activities, including device innovation, concept generation, design reviews, specification development, manufacturing process validation, and design verification.
• Communicate effectively within the team to address concerns and improve efficiency.
• Perform additional activities as required by the Head of Department or designated deputy.

Skills

cGMP compliance

GDP compliance

Equipment qualification

Process optimization

Root Cause Analysis

Project management

Communication

Multi-project coordination

Job description

Are you a Project Engineer with the expertise to optimise manufacturing processes, solve complex technical challenges, and deliver projects in a cGMP-regulated environment?

R&D Partners is seeking a Project Engineer to join a leading pharmaceutical company in ROI. This is a fully onsite contract role offering competitive hourly compensation. The ideal candidate will play a key role in manufacturing and engineering operations, supporting product development, optimizing industrial processes, and ensuring compliance with cGMP standards.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Support product development and launch campaigns.
• Develop and optimize industrial processes from scale-up to commercial production.
• Perform root cause analysis of manufacturing issues.
• Ensure engineering qualification and validation records comply with cGMP, GDP requirements, and relevant SOPs.
• Prepare, review, and update study outlines, protocols, and standard operating procedures to meet cGMP requirements.
• Coordinate with design consultants and user departments for process-manufacturing equipment design.
• Review and approve detailed designs submitted by vendors.
• Manage project execution, ensuring collaboration across departments (QA, QM, Operations) to meet deadlines.
• Conduct FAT-SAT activities for newly installed equipment/systems.
• Oversee installation and operational qualification activities for process-manufacturing equipment.
• Develop lifecycle activities, including device innovation, concept generation, design reviews, specification development, manufacturing process validation, and design verification.
• Communicate effectively within the team to address concerns and improve efficiency.
• Perform additional activities as required by the Head of Department or designated deputy.

Key Skills and Requirements:

• Strong background in manufacturing and engineering within the pharmaceutical industry.
• Expertise in cGMP and GDP compliance.
• Experience with equipment qualification, validation, and lifecycle management.
• Proficiency in root cause analysis and process optimization.
• Excellent communication and coordination skills.
• Ability to manage multiple projects and meet deadlines.

Salary:

• €40.00 – €50.00/Hour

For more information, please contact Billy O’Brien.

By submitting this application, you confirm that you’ve read and understood our privacy policy, which informs you how we process and safeguard your data – https://www.r-dpartners.com/privacy-policy/.