New Product Introduction Engineer

PE Global; Dublin; Hybrid; EUR 70,000 - 90,000; Full time

Job summary

PE Global is recruiting for a NPI Manufacturing Technologist for a leading multinational biotech client based in Dublin. This is a 12-month interim contract with hybrid working arrangements and a focus on delivering New Product Introductions, technology transfers and manufacturing improvements within the Biologics Drug Substance facility.

The role requires strong technical leadership across upstream and downstream operations, risk assessments, change controls and CAPAs, with emphasis on safety,

Qualifications

• Bachelor's degree in Science, Engineering, Biotechnology, Chemical Engineering or a related discipline.
• Minimum of 3 years' experience in Manufacturing Operations, Technical Support, Process Engineering or Equipment Engineering within a biopharmaceutical or highly regulated industry.
• Strong knowledge of biological manufacturing processes and GMP manufacturing environments.
• Experience supporting operations within media preparation, buffer preparation, sterile filtration, upstream and downstream processing.
• Proven experience supporting New Product Introductions (NPI), technology transfers, process validation and capacity expansion projects.
• Experience leading or supporting manufacturing investigations, change controls, deviations and CAPAs.
• Demonstrated experience conducting chemical risk assessments, task-based risk assessments and process safety evaluations.
• Good understanding of GMP, HPRA, FDA and EMA regulatory requirements, together with applicable Environmental Health & Safety legislation.
• Strong analytical, problem-solving and technical leadership skills with the ability to make sound data-driven decisions.
• Excellent technical writing, presentation and training skills.
• Strong communication and stakeholder management abilities across multiple functions and organisational levels.
• Proven ability to work independently while also contributing effectively within cross-functional teams.
• Experience with automation systems, electronic batch records and digital manufacturing technologies is advantageous.

Responsibilities

• Lead New Product Introductions (NPI) and technology transfers.
• Drive CAPEX/OPEX optimisation and continuous improvement.
• Provide real-time troubleshooting and technical leadership in GMP environment.
• Author and review technical documentation including SOPs, batch records and risk assessments.
• Collaborate with MSAT, Quality, Validation, EHS and Operations to ensure project success.

Skills

Analytical skills

Problem-solving

Technical leadership

Communication skills

Training skills

Stakeholder management

Independent working

Education

Bachelor's degree in Science/Engineering/Biotechnology/Chemical Engineering

Job description

PE Global is recruiting for a NPI Manufacturing Technologist for a leading multinational biotech client based in Dublin. This is an initial 12-month contract, hybrid role.

Role Summary

The NPI Manufacturing Technologist will provide technical leadership across upstream and downstream manufacturing operations, supporting the successful introduction of new products, processes, equipment, and technologies within the Biologics Drug Substance (BDS) facility. This 12-month interim contract role will act as a key technical subject matter expert, providing real-time troubleshooting and problem-solving for process, equipment, operational, quality, and safety-related issues while ensuring alignment with site business objectives and manufacturing strategies.

The role is responsible for driving the execution of New Product Introductions (NPI), technology transfers, process improvements, operational excellence initiatives, and capital projects. The successful candidate will also lead and support manufacturing investigations, change controls, CAPAs, chemical risk assessments, task-based risk assessments, and process safety evaluations to ensure all activities are conducted safely, compliantly, and efficiently.

Projects and initiatives may include:

• New process and equipment introduction
• Electronic Batch Record (EBR) deployment and optimisation
• Process automation and digitalisation initiatives
• CAPEX and OPEX optimisation projects
• Process innovation and continuous improvement programmes
• Product and technology transfers
• Process feature optimisation and enhancements
• New material qualifications and introductions
• Equipment commissioning, qualification and validation support
• Manufacturing capacity expansion projects
• Cost reduction and operational excellence initiatives
• Process safety, chemical risk assessments and task-based risk assessments
• Provide technical leadership and subject matter expertise across upstream and downstream manufacturing operations.
• Support manufacturing operations through real-time troubleshooting and resolution of process, equipment, automation and operational issues.
• Lead and support the successful introduction of new products, processes and technologies into the BDS manufacturing facility.
• Provide manufacturing support during PPQ campaigns, validation activities and commercial manufacturing operations.
• Lead and support cross-functional project teams delivering NPI, technology transfer, process improvement and site strategic initiatives.
• Author, review and approve technical documentation including protocols, reports, process descriptions, SOPs, batch records, risk assessments, change controls and CAPAs.
• Lead complex manufacturing investigations and implement effective corrective and preventive actions to prevent recurrence.
• Conduct and facilitate risk assessments including process risk assessments, chemical risk assessments, task-based risk assessments, operational risk assessments and implementation of appropriate controls.
• Ensure compliance with GMP, regulatory, environmental, health and safety requirements while promoting a strong safety culture across all activities.
• Support equipment design reviews, commissioning, qualification and validation activities, ensuring manufacturing and end-user requirements are incorporated throughout project delivery.
• Develop, review and continuously improve manufacturing procedures, work instructions and electronic or paper batch records.
• Identify, lead and implement process optimisation and continuous improvement opportunities to improve safety, quality, throughput, reliability and cost performance.
• Collaborate with Engineering, MSAT, Quality, Validation, EHS and Operations stakeholders to ensure effective project execution and knowledge transfer.
• Deliver technical training and coaching to manufacturing personnel to support operational readiness and sustained process performance.
• Champion the implementation of work practices, error-proofing solutions and operational improvements that minimise human error and enhance Right-First-Time performance.
• Support regulatory inspections, internal audits and quality compliance activities as required.
• Undertake other duties and projects as assigned.

Qualifications & Experience

• Bachelor's degree in Science, Engineering, Biotechnology, Chemical Engineering or a related discipline.
• Minimum of 3 years' experience in Manufacturing Operations, Technical Support, Process Engineering or Equipment Engineering within a biopharmaceutical or highly regulated industry.
• Strong knowledge of biological manufacturing processes and GMP manufacturing environments.
• Experience supporting operations within media preparation, buffer preparation, sterile filtration, upstream and downstream processing.
• Proven experience supporting New Product Introductions (NPI), technology transfers, process validation and capacity expansion projects.
• Experience leading or supporting manufacturing investigations, change controls, deviations and CAPAs.
• Demonstrated experience conducting chemical risk assessments, task-based risk assessments and process safety evaluations.
• Good understanding of GMP, HPRA, FDA and EMA regulatory requirements, together with applicable Environmental Health & Safety legislation.
• Strong analytical, problem-solving and technical leadership skills with the ability to make sound data-driven decisions.
• Excellent technical writing, presentation and training skills.
• Strong communication and stakeholder management abilities across multiple functions and organisational levels.
• Proven ability to work independently while also contributing effectively within cross-functional teams.
• Experience with automation systems, electronic batch records and digital manufacturing technologies is advantageous.

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***