Novartis Internship, Quality Engineering Associate

The Summer Intern will work at a Novartis Gene Therapies site on various activities included, but not limited to, protocol review for equipment and process qualifications, participating in various aspects of facility and equipment commissioning and validation, and work on special projects that help drive process improvements.

Responsibilities of primary importance are to ensure the successful time-sensitive GMP manufacture and release of gene therapy products with minimal to zero deviations, promote a culture of quality and compliance while driving a sense of continuous improvement and operational excellence.  Complete requisite training as well as all applicable policies and procedures related to the specific job function.  The successful candidate will take accountability to ensure all documentation is complete and accurate, so issues can be addressed real time.

• Partner with cross-functional team to facilitate quality review of protocols for equipment and process qualification and commissioning.
• Participate in various stages of validation and commissioning activities related to facility start-up.
• Drive special projects that facilitate the implementation of operational excellence and continuous improvement.
• Provides cGMP observations to management; presents information to employees and management.
• Ensure cGMP documentation is being filled out correctly, training is current, and all Quality requirements are being followed.

• Enrolled in a 4 year program, or recently completed a bachelor’s degree in biochemistry, chemical engineering, bioengineering, or science related field.
• Completed at least two years of college education before beginning the internship.
• Must be enrolled in school the semester following the internship.
• Excellent oral and written communication skills.
• 3.0 GPA.

The level of this position will be based on the final candidate’s qualifications. 

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