Senior Design Transfer Quality Engineer

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

Job summary

GxP Recruitment is seeking an experienced Senior Design Transfer Engineer to support Design Transfer and Design Transfer Quality Assurance (DTQA) activities in a regulated pharmaceutical or medical device environment in Ireland.

You will work with Engineering, R&D, Quality, Manufacturing, Operations and Regulatory teams to ensure designs are ready for manufacturing, verify and validate documentation, and drive successful transfer to production.

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.
• Experience across the full product lifecycle: design and development, verification, validation, and transfer.
• Demonstrated experience supporting Design Transfer or Technology Transfer activities.
• Strong understanding of transferring a product design into a manufacturing environment.
• Experience with specifications, manufacturing documentation, validation and controlled release to production.
• Experience working in cross-functional project teams with multiple stakeholders.

Responsibilities

• Engage with projects early to ensure the product, process and site are ready for 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.
• Translate product designs into component specs, production specs and manufacturing methods.
• Develop work instructions and documentation required for production.
• Ensure that specifications and related documentation released to production are verified and validated.
• Support verification and validation activities associated with Design Transfer.
• Identify Quality, Design Transfer and manufacturing risks and implement mitigations.
• Collaborate with Engineering, R&D, Quality, Manufacturing, Operations, Regulatory and Project Management.
• Provide Quality input into project plans and Design Transfer strategies.
• Ensure Design Control deliverables comply with procedures and regulatory requirements.
• Support resolution of technical and Quality issues during Design Transfer.
• Communicate project status, risks and deliverables to stakeholders.
• Work independently with minimal supervision across multiple projects.
• Support continuous improvement of Design Transfer and Quality processes.

Skills

10+ years' experience

Design Controls

Quality Systems

Cross-functional teams

Project management

Education

Engineering degree or related technical discipline

Job description

We are seeking an experienced Senior Design Transfer Engineer 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
• 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.