
Validation Specialist
Flexible & Integrated Technical Services
- Guayama, PR
- Permanente
- Tiempo completo
- Bachelor's in Life Science or Engineering with three (3+) years of experience in Process Validation activities within the Pharmaceutical Industry.
- Excellent written and verbal skills in both English and Spanish.
- Shift: Administrative and according to business needs.
- Experience in:
- Validation protocol execution and generation for manufacturing equipment
- Strong knowledge of GMP & GDP compliance
- Documentation and execution of IQ/OQ/PQ protocols
- Generate technical justification to support and/or document process changes.
- Design and develop experimental, engineering, or process validation protocols and reports supporting the implementation of operational, process, or raw material changes.
- Support the execution of experimental, engineering, or process validation runs by providing technical assistance at the shop floor.
- Maintain up-to-date process documentation (manufacturing directions, batch records, standard operating procedures) and assure they are in compliance.
- Gather and analyze process data used to monitor process performance and generate product reports.