Validation Specialist I
HR Works
- Las Piedras, PR
- Contract
- Full-time
- Develop and manage decommissioning plans, ensuring all actions are conducted within regulatory compliance, including environmental and safety standards.
- Generate 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.