Senior Technology Transfer Engineer – Process

Fastnet; Munster; On-site; EUR 60,000 - 90,000; Full time

Job summary

Fastnet in Tralee, Co. Kerry seeks a Senior Technology Transfer Engineer (Process) for a 12-month contract to drive sterile injectable product transfers and lead the technical workstream from process characterisation through PPQ strategy.

The role is on-site in Tralee. You will manage process characterisation, risk assessment and engineering batches, and work with Validation to develop PPQ protocols while supporting deviations and equipment readiness activities.

Qualifications

• 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.

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.

Skills

Technology Transfer

Process Engineering

Sterile manufacturing

Risk Assessment

FMEA

Education

Engineering or Science degree

Job description

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.