Process Engineer TPM6066

Tandem Project Management Ltd.; Dublin; Hybrid; EUR 65,000 - 90,000; Full time

Job summary

Tandem Project Management Ltd. is recruiting a Process Engineer for a biopharmaceutical company in West Dublin. The role covers Drug Substance manufacturing support, process improvement, technology transfer, validation and data analytics to optimise manufacturing performance.

You will work with Operations, QA, Automation and Data Analytics teams, analysing GMP data and driving continuous improvement while maintaining compliant documentation.

Qualifications

• Degree qualification in Chemical Engineering, Mechanical Engineering, Pharmaceutical Engineering, Science or related discipline.
• Experience in pharmaceutical/biopharmaceutical manufacturing environments.
• Experience with technology transfer, process validation or scale-up activities.
• GMP knowledge and quality systems familiarity.
• Experience with FDS and process mapping.
• Strong data analytics and MS Office skills (Excel, Word, PowerPoint).
• Excellent communication and stakeholder management skills.
• Exposure to Lean or Six Sigma and project management basics.
• Proven track record of driving process improvements in manufacturing.

Responsibilities

• Provide technical support for Drug Substance manufacturing across product lifecycle.
• Support technology transfer, scale-up, validation and routine manufacturing activities.
• Collaborate with Operations, QA, Automation and Data Analytics teams to enable projects.
• Collect, trend and analyse GMP manufacturing data; apply statistical insights.
• Troubleshoot manufacturing issues and implement effective solutions.
• Identify and deliver continuous improvement initiatives to boost efficiency.
• Support process monitoring activities and recommend improvements from data.
• Maintain technical documentation and support investigations as required.
• Ensure compliance with GMP requirements and site procedures.

Education

Chemical Engineering

Pharmaceutical Engineering

Tools

TrackWise

EQV

Job description

Summary:

A Process Engineer is required for a biopharmaceutical company in West Dublin. The successful candidate will support Drug Substance manufacturing processes, providing technical expertise across manufacturing operations and process improvement initiatives. The role will focus on process engineering activities including technology transfer, process validation, manufacturing support, data analysis and continuous improvement, while working closely with cross-functional teams to optimise manufacturing performance and ensure compliance with GMP standards.

Responsibilities:

• Provide technical support for Drug Substance manufacturing processes across all stages of the product lifecycle.
• Support the introduction and implementation of Event Frames for manufacturing process monitoring and data visualisation.
• Provide technical input throughout technology transfer, process scale-up, process validation and routine commercial manufacturing activities.
• Collaborate with Operations, Technical Services, Quality Assurance, Automation and Data Analytics teams to support manufacturing operations and project delivery.
• Collect, organise, trend and analyse GMP manufacturing data, including statistical analysis to identify opportunities for process optimisation.
• Troubleshoot manufacturing issues and work with site teams to implement effective solutions.
• Identify, scope and deliver continuous improvement projects to enhance manufacturing efficiency, process capability and operational performance.
• Support process monitoring activities and recommend improvements based on manufacturing data and process performance.
• Contribute to cross-functional projects while ensuring compliance with GMP requirements and site procedures.
• Maintain accurate technical documentation and support engineering investigations as required.

Qualifications & Experience:

• Degree qualification in Chemical Engineering, Mechanical Engineering, Pharmaceutical Engineering, Science or a related discipline.
• Experience within a pharmaceutical or biopharmaceutical manufacturing environment.
• Experience supporting manufacturing processes, technology transfer, process validation or process scale-up activities.
• Knowledge of GMP manufacturing environments and quality systems.
• Experience with Functional Design Specifications (FDS) and process mapping.
• Strong analytical skills with experience collecting and interpreting manufacturing data.
• Proficient in Microsoft Excel, Word and PowerPoint, with strong Excel skills preferred.
• Excellent communication and stakeholder management skills.
• Experience with quality systems such as TrackWise, EQV, deviation management or similar systems would be advantageous.
• Exposure to project management methodologies and continuous improvement tools such as Lean or Six Sigma would be beneficial.
• Demonstrated ability to identify process improvements, take initiative and drive positive change within a manufacturing environment.