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Validation & Engineering Group, Inc. · 1 month ago

MF01-111925 CQV Technical Support - SME

Carolina, 031

Full-time

Onsite

Senior Level

7+ years exp

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries. They are seeking a CQV Technical Support - SME to evaluate manufacturing processes, develop qualification strategies, and lead quality assessments.

BiotechnologyConsultingProfessional ServicesQuality Assurance

Responsibilities

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

Qualification

Pharmaceutical industry experienceBiotechnology industry experienceMedical device industry experienceComputer System Development Life Cycle (SDLC)Bilingual (English / Spanish)Technical WritingChange control managementQuality Risk AssessmentManufacturing instructions review