Empleos en Manati, pr, pr
Última actualización: hace 3 días
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CSV Specialist
QRC Group, IncManatí, Manatí, Puerto RicoHace 3 días
Descripción del trabajo
Job Description
CSV Specialist to provide services of commissioning, equipment qualification (IOQ), computer system validation (CSV), forms and SOPs execution for a Keyence and a vision system upgrade project.
Qualifications
- BS or higher in Chemistry / Biology / Microbiology / Computer Science / Information Systems / Engineering or related discipline.
- Background in pharmaceutical products manufacturing environment and in laboratories areas
- More than three (3) years of experience working with PLC’s, Industrial Computers with experience in commissioning and validating laboratory and manufacturing computerized systems in a manufacturing environment, and training in validation methodologies, technologies, and process control computer systems.
- Knowledge on computerized system with data collection software (database).
- Strong knowledge of cGMP, GAMP, SDLC, FDA, 21 CFR Part 11 and Data Integrity Regulations.
- Knowledge in MS Project Management and MS Visio programs.
- Experienced in Instrument Performance qualification, and method configuration
- Excellent skills writing commissioning / validation, and technical documentation in English and using MS Office applications.
- Bilingual (both English / Spanish)
Additional Information
All your information will be kept confidential according to EEO guidelines.