What are the responsibilities and job description for the Validation Engineer II - Houston, TX position at Unicon Pharma Inc?
Description
2-5 years of experience
2-5 years of experience
- Develops validation plans, qualification protocols, compiles and analyzes data, drafts summary reports, and reviews validation documentation to ensure that system are qualified in accordance with applicable regulatory agencies.
- Assures that all validation documentation meets or exceeds the regulatory expectations.
- Hands on experience with validation of equipment and computer system validation for Computerized Systems.
- Able to work with minimal assistance and supervision on validation discrepancies or investigations.
- Performs temperature mapping studies.
- Perform other duties as assigned.
- Hands-on experience in equipment and computer systems, including qualification of Controlled temperature units.
- Strong understanding of regulatory standards and documentation practices.
- Ability to work independently, manage multiple priorities, and resolve validation issues.
- Excellent analytical, and technical writing skills.
