A global life sciences organisation is seeking a Lyophilisation Lead Engineer to support its sterile manufacturing operations in Ireland. The site is part of a wider international network focused on developing and delivering high-quality therapies in areas of significant unmet medical need, including oncology, immunology, urology, ophthalmology, and women's health.
This is a hands-on technical leadership role within a highly regulated GMP environment, offering the opportunity to directly influence process performance, compliance, and continuous improvement in a critical manufacturing function.
Role Purpose
The Lyophilisation Lead Engineer will provide technical expertise and leadership to support lyophilisation operations, ensuring robust, compliant, and efficient manufacturing performance. The role combines process support, deviation management, automation oversight, and continuous improvement leadership.
You will act as a key technical SME for freeze-drying operations and associated control systems, supporting both day-to-day manufacturing and long-term process optimisation initiatives.
Key Responsibilities
- Provide technical support for lyophilisation operations to ensure safe, compliant, and reliable production.
- Lead and support deviations, investigations, root cause analysis, and CAPA implementation.
- Ensure compliance with cGMP, data integrity requirements, and relevant environmental and safety standards.
- Support process validation, equipment qualification, and technology transfer activities.
- Drive continuous improvement initiatives using Lean Six Sigma and operational excellence tools.
- Work closely with QA, Manufacturing, Validation, Automation, and Engineering teams.
- Provide input into SCADA, automation systems, and process control troubleshooting.
- Maintain and update SOPs, technical documentation, and training materials.
- Support and develop operational teams through coaching and technical guidance.
Required Experience & Qualifications
- Degree in Chemical Engineering, Biotechnology, Pharmaceutical Sciences, Bioprocess Engineering, or related discipline (or equivalent experience).
- Strong experience in pharmaceutical or biopharmaceutical manufacturing environments.
- Hands-on exposure to sterile manufacturing and GMP operations.
- Experience in deviation management, investigations, and CAPA processes.
- Familiarity with automated control systems (e.g. SCADA, PLCs, or equivalent).
Desirable Experience
- Direct experience in lyophilisation (freeze-drying) operations or process development.
- Exposure to aseptic vial filling and sterile injectable manufacturing.
- Knowledge of CIP/SIP systems and process validation lifecycle.
- Lean Six Sigma certification or demonstrable continuous improvement experience.
- Experience with PAT tools or advanced process monitoring systems.
- Background in tech transfer or commissioning/qualification activities.
