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. Apply via this advert or contact Siobhan Cummins on 021 4777329 if you have any questions about this role. Find out more about working with LSC at lscconnect.com
