OVERVIEW As a Validation Specialist II, you will be responsible for generating System Development Life Cycle (SDLC) documentation and validating/qualifying systems used in the development and manufacturing of pharmaceutical products. This includes ensuring systems operate within regulations to maintain data integrity and product quality. A key aspect of your role will involve the decommissioning of systems and equipment, ensuring they are appropriately dismantled and disposed of or repurposed in accordance with regulatory requirements and environmental standards. RESPONSIBILITIES - Execute multiple large assigned projects, including the decommissioning of systems and equipment, coordinating closely with clients to ensure project alignment with their needs. - Develop and manage decommissioning plans, ensuring all actions are conducted within regulatory compliance, including environmental and safety standards. - Generate comprehensive documentation throughout the system lifecycle, extending to decommissioning phases, such as Decommissioning Plans, Environmental Impact Assessments, and Decommissioning Reports. - Schedule and execute validations/qualifications per Standard Operating Procedures (SOPs) and regulatory guidelines, encompassing the decommissioning process to ensure minimal environmental impact and compliance with waste management regulations. - Coordinate and communicate all testing and decommissioning activities within company resources and affected functional groups, evaluating outcomes to ensure project goals are achieved. - Conduct thorough risk assessments and validation for the decommissioning of computerized systems, applying industry standards and best practices. - Participate in teams assembled for the specification, installation, validation, troubleshooting, maintenance, and decommissioning of systems and equipment. - Handle Validation deviations and/or participate in deviation investigations during decommissioning processes to identify root causes and define corrective and/or preventative actions (CAPA). QUALIFICATIONS - BS/BA degree in science, engineering, manufacturing technology, or closely related field is required. - Minimum of 3 years of relevant experience in validation, with a strong preference for experience in decommissioning activities within the pharmaceutical, medical device, or related industries. - Excellent attention to detail and working knowledge of FDA Regulations/Guidance, Good Manufacturing Practices, and environmental regulations related to decommissioning and waste management. - Proven ability to manage decommissioning projects, including planning, scheduling, executing, and documentation, ensuring compliance with regulatory and company standards. PREFERRED QUALIFICATIONS - Direct experience in the decommissioning of pharmaceutical manufacturing and packaging equipment, facilities, and utilities. - Knowledge of environmental impact assessments and waste management practices related to decommissioning activities in the pharmaceutical industry. This role is a contract position for a duration of one year, offering a unique opportunity to contribute to the lifecycle management of pharmaceutical manufacturing systems and equipment, including their safe and compliant decommissioning.
