Pleased to say we have partnered with a global CMO for a Validation Engineer to grow with their team! With their market-leading technology and their reputation for being a go-to for pharmaceutical and biotech companies for API Manufacturing needs, they've experienced consistent growth. They just need YOU to be responsible for assuring GxP compliance for their CSV!
RESPONSIBILITIES
- Write CSV protocols as well as equipment master plans and perform testing
- Create and summarize lyophilizer qualification protocols
- See validation projects through their full cycle
- Work cross-functionally with various groups to validate drug product manufacturing processes
- Write and review SOPs, filing documentation, and other cGMP documents
- Train others on how to write, implement, and review studies
- Lead FATs, SATs, IQ/OQ/PQs of facilities, utilities, and equipment in collaboration with both the engineering and Quality teams
REQUIREMENTS
- Experience with steriles is preferred, but proven success working with CMOs will work as well
- 5+ years of validation experience in a cGMP manufacturing environment
- 5+ years of leadership experience in relevant field
- Knowledge of calibration methodology, equipment, and instruments
