NPI Manufacturing Technologist

EFOR; Dublin; On-site; EUR 55,000 - 75,000; Full time

Job summary

EFOR is seeking an experienced NPI Manufacturing Technologist to provide technical leadership across upstream and downstream biopharmaceutical manufacturing operations in Ireland. The role will support the introduction of new products, processes, equipment and technologies, while addressing technical troubleshooting and driving improvements in safety, quality and efficiency.

Key responsibilities include technology transfer, process optimisation, investigations, CAPAs, change controls, risk

Qualifications

• Bachelor's degree in Science, Engineering, Biotechnology or related discipline.
• 3+ years' experience in manufacturing, technical support or process/equipment engineering in biopharma.
• Strong GMP knowledge and experience with upstream/downstream processing.

Responsibilities

• Lead New Product Introduction (NPI) and technology transfer activities.
• Drive process optimisation and continuous improvement initiatives.
• Lead investigations, deviations, CAPAs and change controls.
• Develop, review and approve technical documentation and risk assessments.
• Support equipment design, commissioning, qualification and validation.
• Collaborate with Engineering, MSAT, Quality and Operations teams.
• Provide manufacturing SME support during validation, PPQ and commercial campaigns.

Skills

3+ years experience

GMP knowledge

Biopharma manufacturing

Problem solving

Cross-functional collaboration

Education

Bachelor's degree in Science/Engineering/Biotech

Tools

Automation software

EBR systems

Process validation tools

Job description

NPI Manufacturing Technologist – 12-Month Interim Contract

Role Summary

We are seeking an experienced NPI Manufacturing Technologist to provide technical leadership and support across upstream and downstream biopharmaceutical manufacturing operations.

The role will support the introduction of new products, processes, equipment and technologies, while providing technical troubleshooting and driving improvements in safety, quality, efficiency and manufacturing performance.

Key areas of responsibility include New Product Introduction (NPI), technology transfer, process optimisation, investigations, CAPAs, change controls, risk assessments and capital projects.

Key Projects

• New product, process and equipment introductions
• Technology transfers and process validation
• Electronic batch records and manufacturing digitalisation
• Automation and process improvement initiatives
• CAPEX/OPEX and cost optimisation projects
• Equipment commissioning, qualification and validation
• Manufacturing capacity expansion
• Continuous improvement and operational excellence
• Process safety and risk assessment activities
• Provide technical leadership and SME support across manufacturing operations.
• Troubleshoot and resolve process, equipment, automation and operational issues.
• Lead and support NPI, technology transfer and process improvement projects.
• Provide manufacturing support during validation, PPQ and commercial campaigns.
• Lead or support investigations, deviations, change controls and CAPAs.
• Develop, review and approve technical documentation, SOPs, batch records and risk assessments.
• Support equipment design, commissioning, qualification and validation activities.
• Identify and implement improvements to safety, quality, throughput, reliability and cost.
• Ensure activities comply with GMP, regulatory and EHS requirements.
• Work closely with Engineering, MSAT, Quality, Validation, EHS and Operations teams.
• Deliver technical training and coaching to manufacturing personnel.
• Support audit and regulatory inspection activities as required.

Qualifications & Experience

• Bachelor's degree in Science, Engineering, Biotechnology, Chemical Engineering or a related discipline.
• 3+ years' experience in manufacturing, technical support, process engineering or equipment engineering within a biopharmaceutical or regulated environment.
• Strong understanding of GMP and biologics manufacturing.
• Experience with upstream/downstream processing, media and buffer preparation and sterile filtration.
• Experience in NPI, technology transfer, validation or capacity expansion projects.
• Experience with investigations, deviations, change controls and CAPAs.
• Knowledge of process safety and risk assessment methodologies.
• Strong analytical, problem-solving and technical leadership skills.
• Excellent communication, technical writing and stakeholder management skills.
• Ability to work independently and effectively within cross-functional teams.
• Experience with automation, electronic batch records or digital manufacturing technologies is advantageous.