Csv Laboratory Validation

Perform Decommissioning, Installation/Operational/CSV and SOP Validation Services of the following Laboratory Equipment:
Densitometer Qualification
Fourier-Transform Infrared Spectroscopy (FTIR) Qualification
Refrigerator Qualification

Professional experience and Education required:
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).
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 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)

Job Type: Contract
Salary: $0.00 /hour
Experience:
Laboratory Validation: 5 years (Required)

Contract Length:
5 - 6 months

Full Time Opportunity:
No

Benefits:
None

Schedule:
Other

Work Remotely:
No