Responsibilities of the Validation Associate:
- Have solid experience supporting/driving qualification and validation projects related to the pharmaceutical industry.
- Manage qualification and validation projects from planning stages to completion.
- Create and execute Equipment Qualification Protocols (IQ/OQ/PQ).
- Create and execute cleaning and process validation protocols.
- Create and execute Computerized Systems validation protocols.
- Be responsible for the development of documentation to support computer validation such as User/Functional Requirements specifications, Design Specifications and Risk Assessments.
- Troubleshoot validation issues to maintain the quality of the product and maximize efficiency.
- Support establishing resolutions and impact assessment for validation issues.
- Perform batch record and SOP revisions.
Requirements of the Validation Associate:
- Bachelor’s degree or higher in Engineering, Life Sciences or related discipline and 2-3 years relevant FDA regulated industry/validation experience or an equivalent amount of validation experience.
- Exceptional technical writing, review and analytical skills.
- Knowledge of good documentation practices and cGMPs
Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.