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Specialist, Werum MES

Company: Boehringer Ingelheim
Location: Fremont
Posted on: July 18, 2021

Job Description:

Description:

Boehringer Ingelheim Fremont is the rapidly growing US arm of Boehringer Ingelheim’s Biologics Business Unit. We are a fully integrated biologics operation with over 500 scientist and specialists, covering cutting edge early- to late stage CMC development, clinical and commercial drug substance and drug product manufacturing, medical device assembly for combination products and packaging operations.  

We are continuing our rapid growth, investing over  $200m into the expansion of our capacity and capabilities, and creating approximately 200 new jobs. 

Driving this growth is an exciting pipeline of multiple Boehringer Ingelheim novel biologic entities (NBEs) and biosimilars, as well as, a growing diverse portfolio of therapeutics we develop and manufacture for other leading pharma and biotech companies. This includes multiple commercial product launches planned over the next couple of  years, for which we can tap into Boehringer Ingelheim’s unique experience of having brought 30+ biologics to market globally.

 

Leveraging our diverse talent pool, we are also driving technology and innovation globally, through major investment and collaborations into next generation manufacturing platforms and technologies, which may change how biologics will be made in the future.

 

Whether we work on our own products, help partners to bring their products to market or innovate new technologies and approaches - Everything we do, we do to help patients! 

 

Description\:

 

As part of the Global BioMES Center, provide technical expertise for implementation and support of enhanced capabilities in the BI Fremont BioMES platform. 

 

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\:

  • Provide subject matter expertise to BioMES MBR Designers, including configuration, proof of concept, testing, writing test protocols, training and guidance to system features and best practices.
  • Participate in lifecycle projects, including upgrades and enhancements, as well as new feature adaptations in business processes, including system validation activities as required.
  • Ensures technical system capabilities are used optimally in configurations of electronic batch records.
  • Identifies and drives opportunities for continuous improvement using the BioMES system, collaborating cross-functionally for implementation.

 

Requirements\:

  • Associate degree from an accredited institution with minimum five (5) years of experience; Or
  • Bachelors degree from an accredited institution with three (3) years of experience managing MES (Manufacturing Execution System).
  • Experience with Werum MES and/or pharmaceutical industry preferred.
  • Software development experience.
  • Experience with databases.
  • Organizational skills.
  • Communication skills.
  • Project management skills.
  • Strong analytical skills and understanding of data modeling concepts, as well as technical level understanding of system architecture and design.
  • Strong interpersonal skills and ability to communicate complex technical concepts to a non-technical audience.
  • Understanding and application of system-related compliance requirements, including GMPs, validation, and data integrity.

 

Eligibility Requirements\:

  • 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.

 

Who We Are\:

 

At Boehringer Ingelheim we create value through innovation with one clear goal\: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.

 

Want to learn more?  Visit boehringer-ingelheim.com and join us in our effort to make more health.

 

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race; 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.

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Keywords: Boehringer Ingelheim, Fremont , Specialist, Werum MES, Other , Fremont, California

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