Description

Boehringer Ingelheim is currently seeking a talented and innovative Intern to join our Manufacturing, Process Development department located at our Fremont, CA facility. As an Intern, you will learn and work on the process validation reports that support batch release and BLA submissions. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Duties & Responsibilities

Generate validation documents (protocols/reports) and support execution of validation studies (PPQ, lifetime, mixing validation, etc.)

Support Continued Process Verification (CPV) program for various products at Fremont Biopharma facility including setup parameters for process monitoring in CPV software, update Control Strategy Summary and support protocol/report generation.

Project Objectives

1. Deliver validation reports on time to support batch release and BLA submission

2. Setup parameters for CPV process monitoring and deliver annual CPV reports on time

Student Learning Objectives/Goals

1. Know how to generate validation protocols/reports

2. Learn about data verification process

3. Understand Process Validation and CPV principles

Requirements

• Must be a current undergraduate, graduate or advanced degree student in good academic standing

• Student must be enrolled at a college or university for the duration of the internship

• Overall cumulative minimum GPA from last completed quarter/semester 3.0 GPA (on a 4.0 scale) preferred

• Major or minor in related field of internship

• Undergraduate students must have completed at least 12 credit hours at current college or university

• Graduate and Advanced Degree students must have completed at least 9 credit hours at current college or university

• Must be legally authorized to work in the United States without restriction.

• Must be willing to take a drug test and post-offer physical (if required)

• Must be 18 years of age or older

Desired Skills, Experience and Abilities

All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.