Minimum requirements:
• BS or higher in Chemistry/Biology/Microbiology/Computer Science/Information Systems/Engineering or related discipline.
• At least (10) 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 (i.e. TCP/IP)
• Strong knowledge of cGMP, FDA, 21 CFR Part 11 and Data Integrity Regulations
• Knowledge of DCA, DCS, BAS Systems.
• Experienced in Laboratory Instrument CSV 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)

Knowledge and Expertise:
•    System Audit Trail Review (SATR) and approval for the manufacturing/QC Laboratory area
•    Manage the validation of in-house projects for computer and automated systems for Laboratory, Sterile, Non-Sterile and Utilities/Facilities Operations
•    Manage, execute Data Integrity Assessments for computerized systems 
•    Manage and execute the Computerized Systems Periodic Review Program, including the periodic review of Data Integrity requirements for computerized systems.
•    EBRs, Laboratory Analytical instruments upgrade initiative, and CSV IT Compliance activities including development of validation documents, routing, execution and all related CSV Lifecycle documents.

*Weil Group is proud to be an Equal Employment Opportunity Employer.*