Pharmaceutical & Biotechnology

NPI Manufacturing Technologist

Posted 25 seconds ago
Contract
West Dublin, County Dublin, Ireland
42136521

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

Principal Responsibilities

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.