Validation Specialist

New Yesterday

Who we are LifeSprout is developing revolutionary products for aesthetic and regenerative medicine. Leveraging recent breakthroughs in materials science, we have created a platform that looks and behaves like the body’s own tissues. We are turning this into a suite of products for the millions of patients each year with soft tissue losses from aging, cancer, and metabolic disease. Our next generation products enhance form and function with minimal downtime and superb results.
About the job Position Overview: The Validation Specialist supports validation and maintenance activities essential to the development and manufacturing of medical devices. This role ensures compliance with regulatory standards through the qualification of equipment, software, and processes, contributing directly to product quality and patient safety. Key responsibilities include generating and executing validation protocols, maintaining calibrated equipment, and supporting equipment qualification activities for both manufacturing and quality control laboratory teams. The Validation Specialist also assists in developing and reviewing validation plans, user and functional requirements, protocols, final reports, and change control assessments. This cross-functional role collaborates closely with Engineering, Manufacturing, and Quality teams to maintain a compliant and efficient equipment maintenance and validation programs. Responsibilities: Validation Support Support the development and review of validation plans, protocols, requirements, and final reports. Assist in the execution and documentation of validation activities including Equipment qualification (IQ/OQ/PQ), Software validation and documentation, Test method validation and reporting, Process qualification and data analysis Draft and revise standard operating procedures (SOPs), technical documentation, and change control assessments. Prepare and support validation-related change control requests and impact assessments. Equipment Calibration & Maintenance Coordinate calibration and preventive maintenance activities for lab and production equipment to ensure ongoing compliance and operational readiness. Support onboarding of new equipment, including specification review, installation checks, and qualification. Maintain accurate equipment logs, calibration certificates, and system status tracking in alignment with regulatory and internal standards. Cross-Functional Collaboration Represent the validation function on cross-functional project teams involving Manufacturing, Quality Control, Quality Assurance, and Engineering. Assist in troubleshooting validation-related issues and contribute to corrective and preventive actions (CAPAs). Support internal and external audits and inspections by preparing and presenting validation documentation. Qualifications: Bachelor’s degree in Engineering, Life Sciences, or a related technical field. 0–2 years of experience in validation or within a regulated industry (medical device, biotech, or pharmaceutical). Familiarity with FDA regulations (21 CFR Part 820), ISO 13485, and Good Manufacturing Practices (GMP). Detail oriented, self-motivated, and organized with the ability to prioritize work Ability to easily adapt to change Strong analytical, organizational, and technical writing skills. Proficiency in Microsoft Office Suite (Word, Excel, Outlook); experience with basic data analysis tools. Effective communication and teamwork abilities with a willingness to learn and grow. Eligibility to work in the U.S. is required. Powered by JazzHR yHQFRzHn8C
Location:
Baltimore
Category:
Technology

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