Description
A CQV Engineer – Student Internship – Commissioning Qualification and Validation role is available in the GMS / Small Molecule Department at our Bray location. The successful candidate will support site Validation Maintenance activities, including requalifications and periodic reviews, as well as contribute to validation efforts related to current and future CAPEX and Continuous Improvement projects.
Key Responsibilities
* Qualify equipment, critical systems, facilities, computerized manufacturing systems, cleaning processes, and sterilization processes, as applicable.
* Develop protocols, coordinate validation activities, execute qualification/validation, prepare final reports, and assemble validation packages; generate project plans.
* Prepare, review, and approve documentation for cGMP/Validation of equipment, facility, utility, manufacturing process, cleaning, computerized systems, and automation packages.
* Support validation maintenance activities, including requalifications and periodic reviews, for equipment, facilities, and utilities.
* Promote a culture of cGMP and Quality awareness within the organization.
Requirements
* Bachelor's degree in Engineering or Science, with relevant experience in validation disciplines.
* Excellent technical writing and verbal communication skills.
* Ability to work with site and global SMEs from Engineering, Manufacturing, Quality, Regulatory, and EHS to design, execute, and deliver department goals and project goals.
* Familiarity with FDA cGMP and related regulations, as well as specific knowledge of validation methodologies and principles.
* Strong IT and computer skills, with experience using multiple documentation management systems.