Technology Transfer Engineer – Validation Interface

Fastnet

Munster

On-site

EUR 65,000 - 85,000

Full time

14 days+

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Job summary

Fastnet seeks a Technology Transfer Engineer (Validation Interface) for a 12-month contract in Tralee, Co. Kerry. You will bridge Technology Transfer and CQV, translating transfer requirements into validation deliverables and managing cross-functional interfaces.

The role requires 3+ years in CQV/Validation within GMP pharma, experience with equipment/utilities/process qualification, and a science or engineering degree. Sterile fill-finish experience is advantageous.

Qualifications

  • 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.

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 escalation scheduling or critical-path conflicts between transfer and CQV activities.

Skills

CQV/Validation experience
GMP pharmaceutical experience
Risk-based validation

Education

Science or Engineering degree

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 escalation 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.
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