R&D Validation Specialist

Description Responsible for development and execution of improvement projects for Biologics Manufacturing. Responsibilities include determining project scope, use of lean/FMEA/statistical and other methods to perform preliminary options analysis, change control development and execution, commissioning and qualification documentation development and execution, validation documentation development and execution, project tracking and completion activities.   Skills:         Ability to interact with end users to gather business requirements and information to be translated into project requirements and deliverables.         Ability to interface between operations and support functions, and is expected to work effectively with partner functions such as Quality and Manufacturing Technology.         Must possess strong analytical and communication skills.         Experience writing and reviewing documents following Good Documentation Practices (GMP).         Experience working in a cGMP environment required; biologics or pharmaceuticals preferred.         Must be proficient in use of Microsoft Outlook, Word, and Excel; experience with Microsoft Project, Trackwise, and statistical analysis software (SAS, JMP) preferred. Experience: 3 to 6 years.   Education:   Bachelor's Degree in Science, Engineering, or another technical field.
Salary Range: $80K - $100K
Minimum Qualification
Less than 5 years

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