We have partnered with an innovative Biotech in Middlesex County, MA to find a Sr. Validation Manager to build out their newest facility! They need a leader who can effectively work with vendors and set up validation programs for their newest addition. The ideal candidate will also perform project coordination, vendor selection and management.
RESPONSIBILITIES
- Plan and oversee equipment, utility, cleaning, sterilization, software, and process validation activities
- Create Master plans, protocol development, failure investigations, analysis, and reporting
- Develop SOPs and other regulatory support documents
- Vendor selection and management
- Create and manage compliant equipment calibration program
- Work cross-functionally with facilities, process development, and quality
REQUIREMENTS
- 7+ years of GMP operations experience
- 5+ years of relevant validation experience (Facility, Equipment, and Utility)
- Ability to develop and maintain relationships with various vendors
- Must be able to quickly adapt to changing priorities and projects