What are the responsibilities and job description for the Senior Validation Engineer position at TalentCraft?
Job Summary
This role supports validation activities, including performance qualification of equipment and utilities, environmental qualification, process transfer and scale-up, process validation, and manufacturing support. Responsibilities also include preparing cGMP materials and documentation to meet regulatory standards for new and existing products, such as standard operating procedures (SOPs), technical reports, and risk assessments.
Key Responsibilities
- Generate and execute protocols for installation, operational, and performance qualifications.
- Analyze data and prepare comprehensive reports.
- Review and approve qualification documentation.
- Ensure all qualification activities comply with local procedures, industry standards, and regulatory requirements.
- Investigate protocol nonconformances and site deviations.
- Initiate and manage validation-related change controls and corrective / preventive actions.
- Author SOPs related to validation practices.
- Conduct and document formal risk assessments.
- Develop and implement validation programs.
- Work in cleanroom environments, including aseptic fill-finish operations.
Requirements
Education
Experience
Skills
Work Environment and Physical Requirements
Special Requirements
