Curia is looking to hire a Senior Principal Validation Engineer to oversee Validation Contractors for the Albuquerque expansion and other key site projects, ensuring the validation of equipment, processes, and systems to meet regulatory compliance and quality standards.
Requirements
- Experience with validation tools and processes, including temperature mapping and use of Kaye Validator
- Experience with FDA and EU regulations for pharmaceuticals and validation requirements
- Develop and execute required protocols and complete reports for equipment, process utility, test, and revalidations as assigned.
- Develop and write Standard Operating Procedures for new processes and equipment.
- Ensure change controls, records, and procedures follow current Good Manufacturing Practices (cGMP) as well as Good Documentation Practices (GDPs).
- Review and write validation protocols, final reports, and summaries of work for release of equipment tested.
- Review and approve qualification, validation, re-qualification, and re-validation documents for equipment and manufacturing process protocols and final report.
Responsibilities
- Overseeing validation activities
- Reviewing change controls
- Maintaining validated equipment
- Updating validation documents such as the Validation Master Plan(s)
- Coordinating with departments to ensure timely completion of risk assessments, IQ, OQ, and PQ activities for new components, equipment, systems, and utilities
- Developing and executing validation protocols for processes, equipment, utilities, and test systems
- Providing technical support for validated systems
Other
- Oversees Validation Contractors for the Albuquerque expansion and other key site projects.
- Supervising relevant contractors at the Albuquerque site, including reviewing project proposals, interviewing, completing bid analysis, and selecting contractors.
- Responsible for providing leadership to the contractors supporting the Validation program.
- Provide leadership and guidance to validation staff and contractors in the performance of their duties.
- Ability to work semi-independently; demonstrate ability to interact well with other technical departments
