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Belcan

Validation Engineer

Belcan, San Diego, California, United States, 92189

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Overview

Technical Recruiter @ Belcan - A Cognizant Company Belcan is an equal opportunity employer. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws. Responsibilities

Ensure all company and Site Validation policies and procedures are adhered to. Ensure all work carried out and equipment installed is safe, effective and in compliance with the appropriate industry standards. Ensure all work undertaken is reflected accurately in up to date Validation / project information files. Lead/support the development of process, cleaning, equipment, computer software or facilities qualification protocols and ensures they are in line with Validation policies and guidance documents. Liaising with equipment manufacturers, internal and external project personnel to ensure successful qualification execution. Seek and retain approval for qualification protocols from site User groups (who approve documents from a user group operations perspective) Quality (who approve documents from a regulatory compliance standpoint) Education and Experience

Bachelor's in Mechanical or Chemical Engineering, Science, or related field. At least 5-7 years experience in pharmaceutical/biotech operations Minimum 5 years of direct/ hands on experience with validation of process, cleaning, equipment, computer software or facilities with thorough working knowledge production unit operations and validation principles. Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) required. Technical expertise in biotech unit operations, ability to handle multiple projects at one time.

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