Validation Engineer/Specialist

The Validation Engineer/Specialist will provide support to the engineering and quality department in the validation of products, equipment or process in the Manufacturing and Packaging areas. The successful candidate must have Validation Experience in regulated environment industries such as pharmaceutical, bio-pharmaceutical or medical devices companies.

Requirements

• Solid understanding of FDA Validation guidelines
• GMP and regulatory experience with expertise in process validations
• Experience in writing and executing validation protocols (i.e. DQ, IQ, OQ, PQ)
• Experience in writing SOP's
• Technical Writing experience preferred
• Statistical knowledge, DOE and Quality Process Control experience is preferred
• Project Management knowledge
• Fully Bilingual (English/Spanish)