Mf01 111925 Cqv Technical Support Sme
Carolina, 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:
CQV Technical Support - SME
+ Evaluate current manufacturing process control strategy. Develop qualification/validation strategy.+ Serve as SME to develop and execute qualification packages.
+ Revise and approve qualification documents.
+ Develop sampling plan to be executed during equipment qualification/validation activities.
+ Lead/Facilitate Quality Risk Assessment (RA)
+ Lead and/or participate on triage activities.
+ Own change controls supporting the projects.
+ Review and revise manufacturing instructions and SOPs as applicable to start-up of new equipment
Qualifications:
Bachelor's Degree in Science or Engineering.
Minimum of 7 years of experience in direct pharmaceutical, medical device or biotechnology industries.
Experience in direct process / manufacturing areas. Must be fully bilingual (English / Spanish) with excellent oral skills. SME in the Computer System Development Life Cycle (SDLC) 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 IdJD6183738
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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 LocationCarolina, PR, US, United States
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EducationNot mentioned