Primary Recruiting Services
Validation Manager
Primary Recruiting Services, Jersey City, New Jersey, United States, 07390
Responsibilities
Responsible for validation programs in support of GMP manufacturingResponsible for facility, utility and equipment qualification programsResponsible for QA role in process and assay validation programsReview or author validation related documents such as design specification, URS, FAT, SAT, IQ, OQ, PQ for utility and equipmentAssume QA lead role in software validationMaintain and update validation master plansExecute validation protocols as requiredOversee QA aspects of calibration and preventive maintenance programs used in GMP manufacturingSupervisor, mentor validation staff with the goal of building a sustaining validation teamServe as the primary QA representative for interaction with internal function departments and contractor on validation activitiesQualification
BS/MS in life science or related field12+ years experience in drug/biologics industry in GMP production environment in roles of validation/engineering10+ years experience in facility, utility, equipment, instrument validationExperience in biotechnology facility validation is requiredFamiliar with GMP operational principles and practicesQC experience helpfulWorks independently, self-motivated, and results oriented
Responsible for validation programs in support of GMP manufacturingResponsible for facility, utility and equipment qualification programsResponsible for QA role in process and assay validation programsReview or author validation related documents such as design specification, URS, FAT, SAT, IQ, OQ, PQ for utility and equipmentAssume QA lead role in software validationMaintain and update validation master plansExecute validation protocols as requiredOversee QA aspects of calibration and preventive maintenance programs used in GMP manufacturingSupervisor, mentor validation staff with the goal of building a sustaining validation teamServe as the primary QA representative for interaction with internal function departments and contractor on validation activitiesQualification
BS/MS in life science or related field12+ years experience in drug/biologics industry in GMP production environment in roles of validation/engineering10+ years experience in facility, utility, equipment, instrument validationExperience in biotechnology facility validation is requiredFamiliar with GMP operational principles and practicesQC experience helpfulWorks independently, self-motivated, and results oriented