Bioprocess Technical Operations and Quality Assurance Intern

Bioprocess Technical Operations and Quality Assurance Intern

Keenova is a leading pharmaceutical company dedicated to developing and manufacturing therapies that improve patient lives. We are committed to the highest standards of quality, safety, and regulatory compliance in everything we do.

Keenova is seeking a motivated Intern to join our Bioprocess Technical Operations and Quality team for Summer 2026. This internship offers hands‑on exposure to pharmaceutical systems in a highly regulated GMP environment as well as learning the aspects of Research and Development through hands‑on laboratory operations.

This position contributes to core laboratory operations by preparing buffers, executing experiments, and assisting with fermentation and purification processes under close guidance. This work will provide hands‑on exposure to bioprocess technology, analytical experimentation, and regulated documentation practices.

The intern will also support Quality Assurance Operations, including systems such as Laboratory Management System (LMS), electronic Document Management System (eDMS), and Quality Management Systems (QMS). This will include assisting with documentation review, contributing to compliance activities, and participating in continuous improvement initiatives. Quality Assurance Intern supports projects by compiling data, reviewing, and sorting documents, and following up on action items related to existing projects.

This is an excellent opportunity for students pursuing degrees in life sciences, pharmacy, chemistry, biology, regulatory affairs, or related fields to gain practical industry experience.

• Under close supervision, prepare buffers and execute laboratory experiments in support of the commercial Xiaflex manufacturing process including development, scale up, troubleshooting and deviations.
• Support and/or execute individually or with the larger team in fermentation and/or purification operations in the Bioprocess Technical Operations labs, as directed.
• Maintain equipment and supplies as needed for experimentation and general laboratory upkeep.
• Responsible for accurate and timely documentation of work in lab batch records and/or notebooks.

• To support the completion of migrating quality management systems, assist in reviewing documentation for accuracy in compliance with regulatory bodies, collect and collate metadata appropriately, and compile key metrics and performance indicators.
• Support organization of physical quality documents in document storage for electronic storage and archiving.
• Contribute and assist with data entry, trend analysis, process mapping, planning, and presentation of new policies, procedures and quality events.
• Participate in quality system activities such as deviation/CAPA tracking, change control support, audit preparation, or internal self‑inspection tasks (as appropriate for intern level).

• Participate in quality system activities such as deviation/CAPA tracking, change control support, audit preparation, or internal self‑inspection tasks (as appropriate for intern level).

• Must be currently enrolled in an undergraduate or graduate program.
• Actively enrolled in a relevant field of study such as Biology, Chemistry, Biochemistry, Biochemical Engineering, or other Life Sciences.

• Knowledge of MS suite products.
• Strong written and oral communication skills.
• Proficient in learning and understanding new PC software.
• General knowledge of Biology, Chemistry, Biochemistry, or basic Life Sciences through coursework or other internships.
• Critical Thinking
• Ability to drive to and from work.
• Ability to work independently and collaboratively to facilitate completion of projects.

• Will be working cross functionally at times with other departments, Quality Assurance, Manufacturing, Validation, etc., to assist in completing additional projects.

Onsite role; 5 days/week onsite.

Disclaimer:
The above statements are intended to describe the general nature and level…