The selected candidate will be responsible for the design, approval, management and successful completion of CSV Project for Laboratory Instrument in the Pharmaceutical Industry.
Education: Bachelor degree in Chemistry or Engineering
Experience: At least 5-7 years’ experience in the Pharmaceutical Industry with relevant related experience in Laboratory Capital Project Management. Knowledge on computerized system with data collection software (database). Knowledge with network communications protocol (i.e. TCP/IP). Strong knowledge of cGMP, FDA, 21 CFR Part 11 and Data Integrity Regulations. Knowledge of the Empower platform. Knowledge in Project Management and Visio programs. Experienced in Laboratory Instrument qualification/validation and method configuration. Acquainted with GAMP5 methodology for validations. At least five (5) years of experience working with PLC’s, Industrial Computers or laboratory instrumentation systems. Background in pharmaceutical products manufacturing environment. Good skills writing validation/commissioning, and technical documentation in English and using MS Office applications. Bilingual (both English/Spanish).
Job Types: Full-time, Temporary, Contract
- Pharmaceutical Industry: 5 years (Required)