Responsible for providing technical support for lyophilisation operations, engineering systems, and process control environments to ensure efficient, compliant, and reliable manufacturing performance. Supports investigations, continuous improvement, technology transfer, and operational excellence initiatives within a regulated manufacturing environment.
Key Responsibilities
- Support lyophilisation operations to achieve production and project objectives.
- Ensure compliance with GMP, data integrity, ISO 14001, EMAS, Health & Safety, and environmental requirements.
- Lead deviations, investigations, CAPA activities, and root cause analysis.
- Support and maintain computerised systems, automation, SCADA, and PAT systems.
- Drive Lean Six Sigma and continuous improvement initiatives.
- Support commissioning, qualification, validation, and technology transfer activities.
- Develop and maintain SOPs, technical documentation, and training materials.
- Promote operational excellence, teamwork, and a strong safety culture.
Required Qualifications
- Bachelor’s or Master’s degree in Chemical Engineering, Pharmaceutical Sciences, Bioprocess Engineering, Biotechnology, or related discipline, or equivalent relevant experience.
Preferred Qualifications
- Experience in lyophilisation operations or process development.
- Knowledge of aseptic vial lyophilisation, CIP/SIP/FIT systems, instrumentation, qualification, and validation activities.
- Experience with automation, control systems, and process analytical technologies.
- Strong organisational, analytical, communication, and interpersonal skills.
- Ability to work independently and within cross-functional teams.
Work Environment
- Regulated biopharmaceutical manufacturing environment focused on compliance, operational reliability, continuous improvement, and technical excellence.
