What are the responsibilities and job description for the Fill/Finish Validation Engineer position at TalentCraft?
JOB SUMMARY
The incumbent is responsible for assisting the Validation Manger in completion of all project milestones as well as manufacturing support. This includes performance qualification of equipment and utilities, environmental qualification, process transfer and scale-up, process validation, preparation of cGMP materials and preparation of all relevant documentation to meet regulatory requirements for new and existing products (includes standard operating procedures, technical reports and risk assessments).
ESSENTIAL JOB FUNCTIONS
- Protocol generation, execution support, data analysis, report generation and approval for various installation, operational and performance qualification activities
- Review and approve qualification documentation on behalf of the validation department.
- Ensure performance of all qualification activities is in accordance with local procedures, industry and regulatory guidance.
- Support investigations into protocol nonconformances and site deviations.
- Serve as initiator and owner of validation related change controls and corrective and preventative actions.
- Author standard operating procedures related to validation practices.
- Support the execution and generation of formal risk assessments.
- Support the generation and implementation of validation programs.
- Experience working in clean rooms.
- Experience with aseptic fill finish technique.
EDUCATION / CERTIFCATIONS / LICENSES
ON-THE-JOB EXPERIENCE
KNOWLEDGE, SKILLS AND EXPERIENCE