Computer Systems Validation Specialist

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• CSV Validation Specialist (Lab equipment)

Qualifications:

• Bachelor's Degree in Science or Engineering.
• Minimum of 5 years of experience in direct pharmaceutical, medical device or biotechnology industries.
• Experience in direct process / laboratory areas.
• Must be fully bilingual (English / Spanish) with excellent oral skills.
• Must be proficient using MS Windows and Microsoft Office applications.
• Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
• Experience in Design Documentation (URS, DS), IQ, OQ, PQ, CSV protocols development and execution, deviations and reports generation.
• SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT).
• Strong knowledge of Ellab Data Loggers, Star Oddi Sensors, Keyence Microscopes, Kaye Data Loggers, X-Ray, Bar Code Verifiers.
• Experience with Kneat, CDOCS, Maximo.
• Technical Writing skills and investigations processes.
• Available to work extended hours, possibility of weekends and holidays.

All your information will be kept confidential according to EEO guidelines.