Validation Engineer/Specialist
Flexible & Integrated Technical Services
- Añasco, PR
- Permanente
- Tiempo completo
- Bachelor’s degree in Natural Science (Biology or Microbiology preferred) and previous exposure of Sterilization Validation activities within the Pharmaceutical or Medical Device Industry.
- Excellent verbal/written communication skills (English and Spanish)
- Shift: Administrative & according to business needs
- Ability to work independently and/or collaboratively in order to complete work assignments and tasks.
- Experience in:
- Laboratory (micro).
- Equipment validation protocols development & Ethylene Oxide Sterilization Validation.
- Investigations
- EN ISO 11135, EN ISO 11138 and EN ISO 10993
- Terminal sterilization validation and/or microbiological or laboratory processes.
- Write, execute and maintain on a timely basis Validation protocol.
- Ensure timely, thorough, and complete execution of all protocols, meeting FDA requirements.
- Ensure that all new and existing protocols are effectively integrated into manufacturing processes.
- Ensure documentation is thorough, accurate and entered on a timely basis into the quality system.
- Ensures complete and thorough investigation of all product failures, batch failures and deviations associated with validation sampling and testing.
- Develops documentation of investigations and communicates findings to ensure chance of recurrence is significantly minimized, and resolution satisfies validation requirements.
- Responsible for developing and implementing process strategies, optimizing current processes, and maintaining process documents.
- Support the day-to-day process operations.