Ll01-241028 Validation Specialist
2 semanas atrás
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
- **Validation Specialists**
Qualifications:
- Bachelor's Degree in Science or Engineering.
- **Minimum of 4 years** of experience in direct pharmaceutical, medical device or biotechnology industries.
- Experience in C&Q Projects for Utilities and Facilities, including the following:
- New Facilities
- Compressed Air
- USP Water
- USP Ozone
- Soft Water
- Chiller
- Alcohol
- Nitrogen
- HVAC System (AHU, EF)
- Must be fully bilingual (English / Spanish) with excellent oral skills.
- Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
- Experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation.
- SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT).
- Strong knowledge (according to related area).
- Technical Writing skills and investigations processes.
- **Available to work extended hours, possibility of weekends and holidays.
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