- Mentor Technical Group (Caguas, PR)
- …+ Collaborate with C&Q Engineers to develop and maintain commissioning and qualification procedures and documents. + Write, review, and approve C&Q protocols and ... Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance… more
- Quality Consulting Group (Juncos, PR)
- …Engineering + 4 years of relevant experience + Proficient in validation process, CSV , PV + Proficient in Troubleshooting, Equipment Setups + Proficient in document ... Commissioning / Qualification + Process Validation 4. Computer System Validation ( CSV ) + Manufacturing, Packaging and Laboratory Equipment + Technical experience… more
- Cardinal Health (San Juan, PR)
- …deployment of software solutions aligned with FDA computer systems validation ( CSV ) methodologies. + Define technical requirements in accordance with SDLC, ... platforms as a techno-functional expert preferred + Strong understanding of FDA CSV requirements and methodologies preferred + Gather Requirements, Design and write… more
- Cardinal Health (San Juan, PR)
- …every day. **_Job Overview:_** We are seeking a **strategic** and experienced **Senior Engineer for IT Governance and Compliance** , who will be responsible for the ... CCPA (California Consumer Privacy Act), FDA (Food and Drug Administration)/GxP/ CSV (Computer System Validation), DSCSA(Drug Supply Chain Security Act), as… more
- Quality Consulting Group (Juncos, PR)
- …validation [PV: characterization, OQ, PQ] (not cleaning process) and equipment qualification [ CSV : URS, FAT, IQ, OQ, PQ, TMV] (not laboratory). + Experience in ... production line. + Basic knowledge in defining validation strategies (eg requirements flow down from design to manufacturing). + Experience with Risk Management documentation: pFMEAs. + Basic knowledge in statistics (preferably using Minitab). + Experience… more