Senior Validation Engineer

Review, analyze, and continuously improve the Cleaning Validation Program. Generate and maintain relevant Standard Operating Procedures (SOPs). Assess Cleaning Validation Observations from the FDA, compiling and analyzing data to identify recurring issues in pharmaceutical and biopharmaceutical companies. Prepare a comprehensive plan to address observed issues based on current regulatory expectations. Present findings to clients, showcasing the potential support that Validation Consulting Group LLC can provide to resolve common Cleaning Validation compliance issues. Provide laboratory support for Cleaning Process Validation through CPCI. Support the introduction of new products and conduct relevant cleaning assessments. Assist with the calculation of cleaning validation acceptance criteria. Support the determination of worst-case soil scenarios. Develop and implement a Visual Inspection Program for clients who lack such systems, which includes: SOP for visual inspection Training SOP and materials for the pharmaceutical, biopharmaceutical, and medical device industries. Presentation of the approach at relevant conferences. Exploration of camera usage for post-use cleaning validation, including comprehensive research on existing camera technologies and the identification of new types suitable for inspecting manufacturing equipment. Identification of technologies to ensure the Visual Inspection Program operates independently of personnel. Qualifications: A Master’s degree in a relevant field is required, along with a minimum of 4 years of professional experience in the pharmaceutical or biopharmaceutical industries. An extensive understanding of validation concepts, particularly cleaning and sterilization validation, is a must. Candidates should have up-to-date knowledge of current regulatory standards. Experience in defending during inspections is highly preferred. Knowledge of biopharmaceutical processes and requirements is an advantage. Job Type: Part-time Pay: $35,000.00 - $40,000.00 per year Schedule: 4 hour shift Work Location: Remote