Senior Technology Transfer Engineer – Process

Senior Technology Transfer Engineer (Process) | 12 Month Contract | Tralee, Co. Kerry

Summary :

A 12-month contract opportunity in Tralee, Co. Kerry for an experienced Technology Transfer/Process Engineer supporting sterile injectable product transfers. The role will lead the technical process workstream across process characterisation, risk assessment, engineering batches and PPQ strategy.

Key Responsibilities :

• Lead process characterisation and gap analysis between sending and receiving sites.
• Define and execute engineering batch, scale-up/scale-down and process risk assessment strategies.
• Develop technical content for PPQ protocols in partnership with Validation.
• Support transfer-related deviations, investigations and equipment/utility readiness activities.

Requirements :

• Typically 5+ years’ experience in sterile/aseptic pharmaceutical Process Engineering, Technology Transfer or Process Validation.
• Strong knowledge of EU GMP Annex 1, FMEA/QRA and risk-based process validation.
• Relevant Engineering or Science degree; sterile fill-finish, lyophilisation and/or PPQ experience is highly desirable.