CSV and decommissioning experience and expertise requirements
The resources for this RFP must meet the following minimum requirements in order to be considered:
BS or higher in Chemistry/Biology/Microbiology/Computer Science/Information Systems/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).
Strong knowledge of cGMP, FDA, 21 CFR Part 11 and Data Integrity Regulations
Experienced in Laboratory Instrument Decommissioning execution.
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)
Job Type: Full-time
Pay: $65,000.00 - $90,000.00 per hour
Benefits:
Work Location: In person
