Senior Design Transfer Engineer: Regulated Transitions

GxP Recruitment; Kilkenny; On-site; EUR 90,000 - 120,000; Full time

Job summary

GxP Recruitment seeks an experienced Senior Design Transfer Engineer to support DTQA activities in a regulated pharmaceutical/medical device environment in Ireland. You will drive design transfer from development to commercial manufacturing, ensuring robust Design Controls and Quality Systems.

You will collaborate with Engineering, R&D, Quality, Manufacturing and Regulatory teams, review designs for manufacturability, and guide risk mitigation across multiple projects with minimal supervision.

Qualifications

• 10+ years' experience in a regulated pharmaceutical, medical device, biotechnology or similarly controlled manufacturing environment.
• Strong practical experience with Design Controls and Quality Systems.
• Significant experience across the full product lifecycle: design, verification, validation, transfer.
• Experience supporting Design Transfer or Technology Transfer activities.

Responsibilities

• Engage with projects early to ensure product, process and site readiness for commercialisation.
• Provide expert guidance on Design Controls and Design Transfer requirements.
• Review design outputs for manufacturability and suitability as final specifications.
• Translate product designs into component specs, production specs and manufacturing methods.
• Ensure that documentation released to production is verified and validated.
• Work with cross-functional teams (Engineering, R&D, Quality, Manufacturing, Regulatory) to manage risks and deliverables.

Skills

Design Transfer

Quality Systems

Design Controls

Project management

Cross-functional collaboration

Education

Engineering/Science/Quality

Job description

GxP Recruitment seeks an experienced Senior Design Transfer Engineer to support DTQA activities in a regulated pharmaceutical/medical device environment in Ireland. You will drive design transfer from development to commercial manufacturing, ensuring robust Design Controls and Quality Systems.

You will collaborate with Engineering, R&D, Quality, Manufacturing and Regulatory teams, review designs for manufacturability, and guide risk mitigation across multiple projects with minimal supervision.