Validation SR Manager

2 weeks ago


New York, United States Astrix Inc Full time

Overview: This position is responsible for leading Validation activities (i.e. included but not limited to Manufacturing and packaging equipment qualification, Process validation activities, Cleaning and Sterilization validation activities), that supports commercial and new R&D drug development Manage variety of complex issues in associated projects, plans and schedule project implementation. Responsible for defining scope of work for functional team. Manage, identify, hire, develop and recognize technical staff; the team may include senior level validation engineers, junior level validation engineers and technicians. Provide technical direction.

Qualifications: Master of Science degree in a pharmaceutical sciences, pharmaceutical manufacturing or other related field required. Bachelors with relevant experience might be considered. Minimum two 4 years’ relevant leadership experience performing and managing validation activities within an aseptic pharmaceutical environment is required. Familiarity with current industry practices and guidelines including those required / outlined by the FDA, ISO, EU and ICH. Strong knowledge of 21 CFR


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