What are the responsibilities and job description for the Validation Specialist position at Assure Infusions?
Company Description
Assure Infusions is addressing the critical IV fluid supply chain challenges by building a cutting-edge automated facility in Central Florida. Our mission is to support the healthcare system by providing consistent access to essential medical products and a reliable supply of IV fluids to hospitals and healthcare facilities. Assure Infusions is dedicated to innovation and operational excellence in the medical manufacturing field.
Role Description
This is a full-time, on-site role, located in Bartow, FL. The Validation Specialist ensures that facilities, production equipment, processes, and systems comply with regulatory requirements and industry standards. This roll plays a critical role in maintaining product quality and safety in a cGMP-regulated environment.
Key Responsibilities
· Develop and implement validation protocols (FAT, SAT, IQ, OQ, PQ) for equipment, utilities, and processes.
· Conduct process validation, cleaning validation, and equipment validation.
· Author and review and execute validation plans, protocols, and summary reports.
· Maintain compliance with FDA, State Health Departments and other regulatory guidelines.
· Support regulatory submissions and inspections.
· Identify and implement best practices for validation.
· Perform risk assessments, process gap analysis and propose mitigation strategies.
· Manage multiple validation projects simultaneously.
· Collaborate with engineering department, production, regulatory, quality assurance, and quality control departments.
Required Skills
· Strong knowledge of cGMP, FDA, ICH guidelines, and 21 CFR Parts 11, 210, 211.
· Knowledge in 503B facility and process requirements.
· Excellent organizational, analytical, and communication skills.
· Ability to interpret validation data and prepare detailed reports.
· Proficiency in tools like Word, Excel, and validation management systems.
Education & Experience
· Education: Bachelor’s degree in Life Sciences, Chemistry, Biomedical Engineering, or related field.
· Experience: 3 years in pharmaceutical or biotech validation roles.