Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

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

• QC / Laboratory Equipment -Validation Specialists

Qualifications:

• Bachelor's Degree in Science or Engineering.
• Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries.
• Experienced providing validation support to the quality control laboratory.
• Experienced in the qualification/validation of HPLC methods and routine/non-routine testing lifecycle at the QC laboratories.
• Experienced in method trending and invalid tracking for QC laboratories.
• Skilled in writing and reviewing technical reports.
• Demonstrates strong analytical skills and logical critical thinking.
• Preferred Validation experience must include HPLCs, GCs, Polarimeters, Karl Fischer, Scales, Particle Size Analyzer, ICP/MS, IR, pH meters.
• 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 protocols development and execution, deviations and reports generation.
• CSV protocols generation and execution.
• SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT), if needed.
• Technical Writing skills and investigations processes.
• Available to work extended hours, possibility of weekends and holidays.