Validation Engineer
Flexible & Integrated Technical Services, LLC•Añasco, PR
•Onsite
About The Position
For Validation services in the Engineering & Manufacturing areas.
Requirements
- Bachelor's Degree in Engineering
- Previous exposure to validation quality activities within the Pharmaceutical or Medical Devices industry.
- Bilingual, Spanish and English (good communication)
- Protocol development, execution, investigations, and technical documentation.
- Minitab, JMP, or similar statistical analysis tools.
- GMP & GDP
Nice To Haves
- EO/EtO sterilization processes and validation activities
- Working with external suppliers and supplier qualification projects
Responsibilities
- Development and execution support of validation protocols and reports.
- Change control support (CRs, TRs, VPs, protocol execution, evidence compilation, and closure activities).
- Qualification and operational readiness activities across systems, processes, and infrastructure.
- Cross-functional coordination with Engineering, Quality, Operations, Planning, Supply Chain, and external suppliers.
- Support for SOP updates, training, UAT activities, implementation readiness, and post-implementation support.
- Technical support for supplier qualification and validation activities.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
