CAI is seeking motivated Laboratory CSV Specialists (to cover other disciplines) all to support biotech and pharmaceutical projects in Puerto Rico. These individuals need to reside on the Island or relocate at their own expense for the duration of the contract.
CAI is a 100% employee-owned company providing CQV, start-up, project management and consulting services to FDA regulated and mission critical industries. CAI was established in 1996 and has steadily grown to be an industry leader with 500 employees worldwide.
The Laboratory Computer Systems Validation (CSV) Specialist will develop and execute protocols and test scripts. This person is responsible for writing GxP computer validation and 21 CFR Part 11 related documentation such as assessments, plans, URS, FRS, RTM, and summary reports.
BS or higher in Chemistry/Biology/Microbiology/Computer Science/Information Systems/Engineering or related discipline.
Ability to qualify any lab equipment from end to end; including PQ (Performance Qualification), methodology and assessment, etc.
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)