We are currently searching for a Validation Engineer to provide quality and technical support to the National Institutes of Health.
Duties & Responsibilities
- Provide expertise in the validation of processes, equipment and build/commissioning of Aseptic Processing Facilities (APFs) across the NIH.
- Facilitate the development and review of project plans, qualification protocols and reports for all stages of the qualification process, while maintaining quality standards with FDA cGMP, USP, ICH and other regulatory guidance.
- Develop and implement Validation Plans for the Environmental Monitoring Systems in multiple new and existing facilities.
- Develop and implement Validation Master Plans for new APFs including the 12E CCE facility, interim/Permanent NMD Radiopharmacy and future viral seed stock facility.
- Review and update validation documents for current APFs.
- Serve as a subject matter expert for the Legacy Facility Project.
- Provide expertise in the harmonization of various documents between ORSC and ORF including the URS, VMP, SLIA and RA as well as development of EMS and BAS parameters.
- Develop the validation plans for MasterControl UAT Execution for eForms.
- Support Lessons Learned/Continuous Improvements programs.
- Develop FCIS/DFOM Web Portal/Dashboard.
- Bachelor’s degree in a related field.
- Minimum of five (5) years of experience developing and performing validations in a cGMP environment.
- Strong interpersonal skills to deal effectively with a wide range of audiences.
- Excellent analytical and writing skills to prepare meeting materials, technical and administrative correspondence, and reports.
- Strong organizational skills and the ability to prioritize complex tasks.
- Time management and organizational skills to work efficiently and independently or as part of a team.
The proposed salary range for this position is $115,000 to $120,000. Final salary will be determined based on various factors such as geography, experience, certifications, etc.
Dovel Technologies and its Family of Companies (Medical Science & Computing and Ace Info Solutions) was acquired in October 2021.
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