NPI Biologics Manufacturing Technologist (Hybrid, Dublin)

PE Global (UK)

Leinster

Hybrid

EUR 70,000 - 110,000

Full time

14 days+

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Job summary

PE Global is recruiting for an NPI Manufacturing Technologist for a leading multinational biotech client based in Dublin. This 12-month hybrid contract role provides technical leadership across upstream and downstream manufacturing, supporting the successful introduction of new products, processes, and technologies within the Biologics Drug Substance facility.

The ideal candidate will lead NPI programs, technology transfers, CAPAs and risk assessments, ensure GMP compliance, and collaborate with

Qualifications

Bachelor’s degree in Science, Engineering, Biotechnology, Chemical Engineering or related discipline.
Minimum of 3 years’ experience in Manufacturing Operations, Technical Support, Process Engineering or Equipment Engineering within a biopharmaceutical or regulated industry.
Strong knowledge of biological manufacturing processes and GMP environments.
Experience supporting NPI, technology transfers, validation and capacity expansion projects.
Experience leading or supporting manufacturing investigations, deviations and CAPAs.
Knowledge of GMP, HPRA, FDA and EMA regulations.
Excellent technical writing, presentation and training skills.
Strong communication and stakeholder management across multiple functions.
Ability to work independently while also contributing in cross-functional teams.

Responsibilities

Provide technical leadership across upstream and downstream manufacturing operations.
Troubleshoot process, equipment, automation and operational issues in real time.
Lead introduction of new products, processes and technologies into the BDS facility.
Support PPQ campaigns, validation activities and commercial manufacturing.
Lead cross-functional project teams delivering NPI, tech transfers and site initiatives.
Author, review and approve technical documentation including protocols, reports, SOPs and CAPAs.
Lead complex manufacturing investigations and implement CAPAs.
Conduct and facilitate risk assessments with proper controls.
Ensure GMP, regulatory and EH&S compliance.
Collaborate with Engineering, MSAT, Quality, Validation, EHS and Operations.
Deliver technical training and coaching to manufacturing personnel.
Champion work practices to minimise human error and improve Right-First-Time performance.
Support regulatory inspections and internal audits.