Csv Laboratory Specialist

Minimum requirements to be considered:
BS or higher in Science, Engineering or related discipline.
More than Five (5) years of experience validating laboratory 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).
Knowledge with network communications protocol.
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 Performance qualification, execution and method configuration.
Acquainted with GAMP5 methodology for validations.
At least three (3) 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)