Ll02 032525 Validation Specialist (drug Substance)
Juncos, PR, US, United States
Job Description
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 position:
Validation Specialist for Drug Substance 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 drug substance process / manufacturing 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 protocols development and execution, deviations and reports generation. SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT).
Strong knowledge in drug substance equipment C&Q (Bioreactors, Mixing, Filtration, Centrifuges, Incubators, Chromatography Systems, Lyophilizers)
Technical Writing skills and investigations processes. * Available to work extended hours, possibility of weekends and holidays.
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Job Detail
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Job IdJD5525662
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationJuncos, PR, US, United States
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EducationNot mentioned