Technology Transfer Engineer – Validation Interface

Fastnet; Munster; On-site; EUR 55,000 - 85,000; Full time

Job summary

Fastnet in Tralee, Co. Kerry, is seeking a Technology Transfer Engineer (Validation Interface) for a 12-month contract to support a major Technology Transfer/NPI programme.

You’ll act as the key interface between Technology Transfer and CQV, translating transfer requirements into validation deliverables and coordinating qualification activities. The ideal candidate has 3+ years' CQV/validation experience in a GMP pharmaceutical environment, with knowledge of equipment, utilities and process

Qualifications

• 3+ years CQV/Validation experience in GMP pharma environment.
• Experience across equipment, utilities and/or process qualification with knowledge of risk-based validation principles.
• Relevant Science or Engineering degree; sterile fill-finish equipment and utility qualification experience is advantageous.

Responsibilities

• Translate Technology Transfer requirements into validation protocols, QRAs and associated deliverables.
• Coordinate equipment and utility readiness and prior-qualification status for product transfers.
• Track transfer-related validation dependencies within the wider CQV programme.
• Identify and escape scheduling or critical-path conflicts between transfer and CQV activities.

Job description

Technology Transfer Engineer (Validation Interface) | 12-Month Contract | Tralee, Co. Kerry

Summary:

A 12-month contract opportunity in Tralee, Co. Kerry for an experienced CQV/Validation professional to support a significant Technology Transfer/NPI programme. You’ll act as the key interface between Technology Transfer and CQV, ensuring transfer requirements are effectively translated into validation deliverables.

Key Responsibilities:

• Translate Technology Transfer requirements into validation protocols, QRAs and associated deliverables.
• Coordinate equipment and utility readiness and prior-qualification status for product transfers.
• Track transfer-related validation dependencies within the wider CQV programme.
• Identify and escape scheduling or critical-path conflicts between transfer and CQV activities.

Requirements:

• Typically 3+ years' CQV/Validation experience within a GMP pharmaceutical environment.
• Experience across equipment, utilities and/or process qualification with knowledge of risk-based validation principles.
• Relevant Science or Engineering degree; sterile fill-finish equipment and utility qualification experience is advantageous.