Radiochemist Engineer

1. Production of radiopharmaceutical medicinal products (RPM) in accordance with regulatory documentation and Good Manufacturing Practice rules.
2. Preparation of cleanrooms in accordance with ISO 14644, preparation of equipment, reagents, and materials for work. Control and execution of synthesis, filling into primary packaging, and unloading of RPM into secondary packaging.
3. Timely maintenance of documentation (compiling batch dossiers, filling out logbooks, equipment logs, protocols, and electronic spreadsheets for product accounting, raw material and material consumption).
4. Participation in deviation investigations and preparation of reports.
5. Monitoring of room temperature and humidity.
6. Development and updating of technological documents (instructions, logbooks, completed forms).
7. Development of a near-term maintenance program for production equipment based on equipment status information.
8. Conducting equipment qualification, development of protocols, and preparation of reports.
9. Conducting production process validation, development, and preparation of reports.
10. Participation in commissioning of new production equipment.
11. Participation in repair work and maintenance work together with equipment service specialists.
12. Participation in the development and implementation of technological processes and installations.
13. Creation of technologically justified requests for equipment, spare parts, ionizing radiation sources, chemical reagents, glassware, and standard samples.
14. Ensuring the correct operation of production group equipment.
15. Compliance with requirements for sanitation, personal hygiene, radiation safety, fire safety, and occupational safety.
16. Participation in: complaint investigations; investigations into the causes of non-conformities (deviations); self-inspections; supplier/contractor audits, compilation of the Approved Supplier List and Approved Contractor List; impact assessment and preparation of change implementation plans; risk analysis.

Requirements

• Basic education: Specialist degree, Master's degree (chemical, chemical-technological, biotechnological) - Experience (how many years and in which profile): At least 1 year in the production of radiopharmaceutical medicinal products - Additional competencies: English language (technical).

Higher education — Specialist degree, Master's degree; Experience: 1 year

Conditions

Permissible