Process Validation Engineer

Company Description

ZEO ScientifiX™, headquartered in South Florida (Davie, FL), is a publicly traded biotechnology company specializing in the research, development, and production of cutting-edge biologic medicines- specifically exosome and stem cell biologics. The company is dedicated to transforming regenerative medicine through advanced cell-derived therapies.

Role Description

We are seeking a full-time Process Validation Engineer to join our team in Davie, FL. This on-site role involves designing, executing, and documenting process validation protocols to ensure compliance with regulatory requirements and Good Manufacturing Practice (GMP) standards.

Key responsibilities include testing new product manufacturing protocols, conducting verifications of existing protocols and processes, identifying and debugging process-related issues, optimizing workflows, and collaborating with cross-functional teams to maintain high-quality standards in the manufacturing lab.

The Process Validation Engineer will play a critical role in collecting data to demonstrate proper function of technical SOPs and operational activities in the lab.

Qualifications

• Experience with Validation and Good Manufacturing Practice (GMP)
• Proficiency in experimental design, writing and completing experiments.
• Problem-solving mindset with a focus on process optimization
• Excellent collaboration and communication skills to work effectively with cross-functional teams
• Bachelor’s degree in Engineering, Biotechnology, or a related technical field
• Prior experience in the biotechnology or pharmaceutical industry is highly preferred
• Working knowledge of regulatory standards and requirements for process validation