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Associate Director, Site Technical Services
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$134,400 - $184,400 a year
Full-time
- General Description:The Associate Director Site Technical Services is responsible for the day-to-day activities of the Validation team, Metrology, CMMS and other technical services functions.
- Note: This is an on-site role (5 days/week) based in Hopewell, NJ.Essential Functions of the job:Develop and approve cGMP documents including, but not limited to: Validation Protocols and Reports, Commissioning Reports, Master Validation Plans, SOP’s, Comparability Reports, Aseptic Process Simulation Protocols and Reports, Cleaning Validation, Process Validation (PPQ).
- Experience in Metrology principals, CMMS functionality, and SOP authoring.
- Project planning and execution including scheduling, task management, milestone planning and reportingGeneration, review, and approval of project documentation (User Requirement Specifications, validation protocols, reports) and Standard Operating ProceduresLead or manage validation activities for project activities including review of validation documentation and attendance at validation activities (FAT, IQ, OQ, PQ, etc
- Maintaining the validation sample management, assessing the requirements for data acquisition, and coordinating validation projects.
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