Lead Process Transfer Engineer — Sterile Pharma

LSC, Life Science Consultants; Munster; On-site; EUR 70,000 - 110,000; Full time

Job summary

Life Science Consultants in Kerry is seeking a Senior Technology Transfer Engineer - Process to drive sterile injectable process transfers from development to production. You will lead cross-functional teams, perform risk assessments, and define strategies for scalable, compliant processes.

The role requires 5+ years in sterile pharma, strong knowledge of validation and Q9/QRM principles, and hands-on PPQ protocol experience.

Qualifications

• Significant experience (5+ years) in sterile/aseptic pharmaceutical process engineering or technology transfer.
• Familiar with EU GMP Annex 1 (2022) and risk-based validation (ICH Q9).
• Experience with FMEA/QRA and risk-based sampling strategies.

Responsibilities

• Lead process characterisation, gap analysis, and risk assessments between sending and receiving sites.
• Define and execute process strategies including scale‑up/scale‑down studies and risk evaluations.
• Author technical content for PPQ protocols with Validation teams.
• Support root cause investigations for process deviations during transfers.
• Provide engineering input for equipment and utility readiness reviews.
• Mentor junior team members and new Phase 2 Technology Transfer Engineers.

Skills

Sterile process engineering

Technology transfer

FMEA / QRA

Process validation

Team leadership

Cross-functional collaboration

Education

Engineering degree in pharma/manufacturing

Job description

Life Science Consultants in Kerry is seeking a Senior Technology Transfer Engineer - Process to drive sterile injectable process transfers from development to production. You will lead cross-functional teams, perform risk assessments, and define strategies for scalable, compliant processes.

The role requires 5+ years in sterile pharma, strong knowledge of validation and Q9/QRM principles, and hands-on PPQ protocol experience.