The role of Technical Specialist is responsible for providing scientific support the manufacturing and validation of the processes.
You will be required to collaborate and facilitate running of activities (PPQ batch manufacture, validation activities, investigations, change control) to ensure the effective and efficient on-time delivery of these activities.
- Responsible for the technical support of manufacture .
- Inputing into Technical planning and decisions
- Ensuring supply of high quality product through tactical planning and execution of production schedules.
- Leading and closing process related deviations and reports
- Protocol/report authoring/execution/oversight/approval as appropriate
- Cleaning validation activities, Periodic reviews, Requalification of equipment
- Contributing for driving a culture of Continuous Improvement
- Stakeholder management of multiple decision makers, corporate colleagues, cross-functional team by demonstrating the ability to maintain and strengthen trust relationships with people on all levels
- 3+ years’ experience in biopharmaceutical/vaccines environment
- Demonstrated knowledge in pharmaceutical / biopharmaceutical technical / manufacturing operations.
- Knowledge of Regulations and applicable standards for Quality, Safety, Regulatory within the biopharmaceutical/vaccine area.
- Experience in Validation activities e.g. Cleaning Validation, Requalification
- Hon. Degree or Masters in a Science or Engineering discipline.
- Evidence of Continuous Professional Development
- Demonstrated knowledge in more than one pharmaceutical or Biopharmaceutical manufacturing operation (e.g. manufacturing, technology, validation, engineering, quality.).
- Advanced PC skills such as Excel, Word, PowerPoint.
- Stakeholder management of multi decision makers, colleagues, peers and cross functional teams.
- Experience in a FDA / HPRA Regulated production environment.
For a confidential discussion on this or any other current job opportunity please contact Marcel Skolimowski on 021 4847 138 / marcel at sigmar.ie
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