Senior Technology Transfer Engineer Process

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

Senior Technology Transfer Engineer - Process - Kerry

Are you a seasoned process engineer with a passion for advancing sterile injectable manufacturing and technology transfer? Join our dynamic team as a Senior Technology Transfer Engineer - Process, where you'll play a pivotal role in shaping the seamless transfer of innovative pharmaceutical products from development to production. This is your chance to lead technical process workstreams for state-of-the-art sterile facilities, ensuring robust, compliant, and efficient processes from start to finish.

Bring your expertise and drive to a role where your technical leadership fuels impactful projects and supports the delivery of life-saving medicines worldwide.

Key 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 in collaboration 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.

Required Skills:

• Significant experience (typically 5+ years) in sterile/aseptic pharmaceutical process engineering, technology transfer, or process validation.


• Strong knowledge of EU GMP Annex 1 (2022) and risk-based process validation principles (ICH Q9(R1)).


• Hands-on experience with FMEA/QRA methodology and risk-based sampling strategies.


• Proven ability to lead process characterisation, gap analysis, and technical batch strategy definition.


• Excellent collaboration and communication skills with cross‑functional teams, including Tech Transfer, Manufacturing, CQV/Validation, QC, and process engineering.

Preferred Education and Experience:

• Degree in engineering or scientific discipline relevant to pharmaceutical manufacturing.


• Direct experience with isolator/RABS filling, VHP bio‑decontamination, lyophilisation, or liquid‑fill operations.


• Hands-on experience authoring or executing PPQ protocols for sterile injectables.


• Experience managing process scale‑up or scale‑down across multiple sites.

Are you currently eligible to work in Ireland? As this is a contract opportunity, you will need to hold a Stamp 1G or Stamp 4 visa to apply.

Find out more about working with LSC at lscconnect.com