Senior Quality Engineer - Design Transfer

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

Job summary

GxP Recruitment seeks an experienced Senior Quality Engineer - Design Transfer (Analytical Methods) to support DTQA activities in a regulated pharmaceutical or medical device environment.

The role focuses on ensuring designs are ready for commercialisation, guiding on Design Controls, reviewing design outputs for manufacturability, and translating designs into production-ready documentation while managing risks across multiple projects with minimal supervision.

Qualifications

• 10+ years of 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 including design, verification, validation and transfer.

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 to ensure manufacturability before final product specs.
• Translate product designs into component specs, production specs and manufacturing methods.
• Ensure that documentation released to production is verified and validated.
• Plan and execute verification and validation activities for Design Transfer.
• Identify quality, design transfer and manufacturing risks and mitigate them.
• Collaborate with Engineering, R&D, Quality, Manufacturing, Operations, Regulatory and PM teams.
• Provide Quality input into project plans and commercialisation activities.
• Ensure Design Control deliverables comply with procedures and regulatory requirements.
• Support resolution of technical and quality issues throughout Design Transfer.

Skills

10+ years experience

Design Controls

Design Transfer

Quality Systems

Cross-functional teams

Regulated environment

Education

Engineering/Science degree

Job description

We are seeking an experienced Senior Quality Engineer - Design Transfer (Analytical Methods) to support Design Transfer and Design Transfer Quality Assurance (DTQA) activities.

The position is suited to a senior-level Quality or Design Transfer professional with extensive experience in a regulated pharmaceutical or medical device environment, and a strong understanding of the journey from product design and development through verification, validation, transfer and commercial manufacturing.

Key Responsibilities

• Engage with projects at an early stage to ensure the product, process and manufacturing site are ready for successful commercialisation.
• Provide expert guidance on Design Controls and Design Transfer requirements.
• Review design outputs to ensure they are suitable for manufacturing before they become final product specifications.
• Support the effective translation of product designs into:
• Component specifications; Production specifications & Manufacturing methods
• Work instructions and procedures & other documentation required for production
• Ensure that specifications and associated documentation released to production have been appropriately verified and validated.
• Support the planning and execution of verification and validation activities associated with Design Transfer.
• Identify potential Quality, Design Transfer and manufacturing risks and ensure appropriate mitigation actions are implemented.
• Work closely with Engineering, R&D, Quality, Manufacturing, Operations, Regulatory and Project Management teams.
• Provide Quality input into project plans, Design Transfer strategies and commercialisation activities.
• Ensure appropriate Quality documentation and Design Control deliverables are completed in accordance with applicable procedures and regulatory requirements.
• Support the resolution of technical and Quality issues throughout the Design Transfer process.
• Provide clear communication of project status, risks, issues and deliverables to relevant stakeholders.
• Work independently and proactively, managing priorities across multiple projects with minimal supervision.
• Support continuous improvement of Design Transfer and Quality processes across the organisation.

Required Experience & Qualifications

• Degree in Engineering, Science, Quality, or a related technical discipline.
• 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, including:
• Product design and development; Design verification; Design validation; Design Transfer

& Process development experience

• Manufacturing/operations & Commercialisation experience
• Demonstrated experience supporting Design Transfer or Technology Transfer activities.
• Strong understanding of the requirements for transferring a product design into a manufacturing environment.
• Experience with specifications, manufacturing documentation, validation and controlled release of documentation to production.
• Strong understanding of regulated Quality requirements and associated documentation.
• Experience working within cross-functional project teams and managing multiple stakeholders.