Senior Process Transfer Engineer - Sterile Injectables

LSC, Life Science Consultants; Munster; On-site; EUR 80,000 - 120,000; Full time

Job summary

Life Science Consultants (LSC) in Kerry invites an experienced Senior Technology Transfer Engineer - Process to lead sterile injectable technology transfer from development to production. You will drive process characterization, scale-up studies, and PPQ strategy, ensuring compliant and robust transfer across sites with a focus on risk management and QA collaboration.

The role requires 5+ years in sterile/pharmaceutical processing, strong knowledge of EU GMP Annex 1 and ICH Q9(R1), and hands-on

Qualifications

• 5+ years in sterile/pharma process engineering or technology transfer.
• Knowledge of EU GMP Annex 1 (2022) and ICH Q9(R1) risk-based validation.
• Hands-on experience with FMEA/QRA and sampling strategies.
• Proven ability to lead process characterization, gap analysis, and technical batch strategy.
• Excellent collaboration with Tech Transfer, Manufacturing, CQV/Validation, QC, and process engineering.

Responsibilities

• Lead process characterisation, gap analysis, and risk assessments (FMEA) between sending and receiving sites.
• Define and execute process strategies, including scale-up/scale-down studies and process 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 and guide junior team members, including new Phase 2 Technology Transfer Engineers.

Skills

Sterile processing

Technology transfer

Process validation

FMEA / QRA

Risk-based sampling

Process characterization

Gap analysis

Technical batch strategy

Cross-functional collaboration

Education

Engineering degree or scientific discipline

Job description

Life Science Consultants (LSC) in Kerry invites an experienced Senior Technology Transfer Engineer - Process to lead sterile injectable technology transfer from development to production. You will drive process characterization, scale-up studies, and PPQ strategy, ensuring compliant and robust transfer across sites with a focus on risk management and QA collaboration.

The role requires 5+ years in sterile/pharmaceutical processing, strong knowledge of EU GMP Annex 1 and ICH Q9(R1), and hands-on