EB Validation Services

VALIDATION SPECIALIST / ENGINEER

Description:

Responsible for the development, execution, and final reporting for equipment and utility IQ, OQ, PQ protocols within FDA regulated industries including pharmaceutical, biotechnology, and medical devices. Other responsibilities include maintaining direct communication with Project Managers and clients to ensure that validation deliverables are properly developed in compliance with corporate and federal policies and procedures.

Please include in your Resume any direct experience with common isystems as: Manufacturing Equipment, Packaging Lines, Utilities, Laboratory Instrumentation, and others

Requirements:

·          Bachelor's or Master's degree in Engeneering or Science, or equivalent work experience

·          4 years as validation specialist within FDA regulated industries including pharmaceutical, biotechnology, and medical devices

·          Knowledge of FDA regulations and their impact on validation

·          Excellent verbal and written communication skills (English and Spanish)

·          Computer Literate – excellent skills in Windows and Microsoft Office applications

COMPUTER SYSTEM VALIDATION SPECIALIST

Description:

To participate in computer validation and 21 CFR Part 11 compliance activities for our clients within FDA regulated industries including pharmaceutical, biotechnology, and medical devices.

Please include in your Resume any direct experience with common computerized systems as: PLCs, SCADA, Oracle, DCS, Empower, SAP, Oracle, ERP/MRP, LIMS systems, Laboratory Instrumentation, Document Management, and others

Requirements:

·          Bachelor's or Master's degree in IT or Computer Science related subject, or equivalent work experience

·          4 years as validation specialist within FDA regulated industries including pharmaceutical, biotechnology, and medical devices

·          Knowledge of FDA regulations and their impact on computerized systems validations

·          Excellent verbal and written communication skills (English and Spanish)

·          Experience in 21 CFR Part 11 assessments and remediation planning, and the software lifecycle approach as per GAMP4

·          Computer Literate – excellent skills in Windows and Microsoft Office applications