Master Associate, BioMES Modeler
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!
This position is responsible to design and generate electronic batch records for cell culture, purification and fill finish operations within a highly complicated electronic system (BioMES) based upon the large scale process description. BioMES is a highly complex operating system utilized for RM inventory management and electronic batch records. The Master Associate will stay abreast of industry trends, upcoming software changes and regulatory expectations related to computer systems and electronic batch record design. The modeler will determine the most efficient way to design records based upon software limitations and business needs. The modeler is responsible to maintain Master data such as Equipment, Product-Codes, etc. within BioMES, in close cooperation with other departments such as Quality and Supply Chain.
The BioMES Modeler participates in project teams and leads team members to meet time lines, proposes and implements improvements, drives consistency in content and processes and communicates progress to cross functional audiences. The modeler is accountable to create clear, consistent and efficient quality batch records in advance of scheduled operation.
The BioMES modeler is responsible to train manufacturing operators on the flow of the batch record and the execution the batch record when a new batch record type is being implemented.
The modeler is responsible to drive continuous improvement in BioMES business processes, system and batch records themselves. This is realized through project management skills and cross functional team leadership.
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
Create electronic batch records within BioMES\:
Leads team to complete testing of and review electronic batch records on time, and in a quality manner. Determines and implements improvements to business and batch record processes.
Maintain master data such as equipment and product codes
The modeler is responsible to drive continuous improvement in the business processes, BioMES system aspects and batch records. This is realized through project management skills and cross functional team leadership.
Create consistent, error-free batch records that are standardized to decrease complexity and exceptions, and to improve flow and sequencing for employees.
Must have a strong understanding of new product introduction and multiproduct operations. Support troubleshooting efforts relative to BioMES. Must be able to collect, interpret and give suggestions for process and product improvement. Must be familiar with LEAN and six sigma methodologies.
Stay abreast of industry changes and expectations related to computer systems and electronic batch record design and to influence changes to software such that it continues to meet the needs of the business.
Train Manufacturing staff on the flow of the batch record and how to execute the batch record when implementing a new batch record type.
Create training materials and train new modelers in a highly complex electronic system.
Provides training and guidance to others.
Collaborates within team and department in order to follow best practices and meet department goals. Report any issues related to manufacturing performance, process and safety to the manager in order to ensure safety, compliance with regulations and cGMPs and to facilitate continuous process improvement.
Requires a Bachelor’s degree from an accredited institution, preferably in a science or engineering related field, and a minimum of three (3) to five (5) years closely related experience in with GMP procedures in a Pharmaceutical manufacturing environment.
In lieu of a Bachelor's degree, will consider a minimum of eight (8) years closely related experience in a GMP bulk manufacturing environment with an Associates Degree from an accredited institution or ten (10) years closely related experience in a GMP bulk manufacturing environment with a High School Diploma or equivalent.
Experience with continuous process improvements
Must be organized and understand manufacturing operations.
Demonstrated ability to organize and lead small work groups.
Demonstrated ability to read, comprehend, and follow written instructions.
Computer skills with the able to troubleshoot challenges within a complex computer software system.
Demonstrated written and verbal communication skills are required.
Must be able to work in a team environment.
To be qualified for this position must meet the following\:
Physical Demands / Surroundings - Requires physical activity such as almost constant standing, walking, eyestrain, etc.. Works regularly under desirable conditions with some moderately disagreeable conditions in the manufacturing setting.
Visual Demands - Position requires constant use of computer terminals and routine / repetitive work.
Temperaments/Mental Requirements - The position requires concentration as errors might cause moderate to serious delays, confusion, or expense to correct. The position has some contact with other departments and the associate must be able to discuss issues and ideas with an open mind and even temper.
Level of Proficiency - Experienced level subject matter proficiency required
Attendance / Schedule - The schedule is dependent on the shift for which the associate is hired. Attendance requirements are based on general attendance policies.
To remain in this position, employees\:
Must obtain & maintain qualifications, as required, to perform the assigned work.
Must understand, will be held accountable for and must adhere to all SOPs, company Policies and Procedures
Must adhere to proper technique, proper documentation practices, and all other aspects of the cGMP’s
Must maintain all training requirements and regularly checks the LOS training system in order to complete all required training on time.
Desired Skills, Experience and Abilities\:
Subject matter expert relative to manufacturing and BioMES records.
Ability to transform/translate process information/design from process description into a BioMES Master Batch Record
Experience with manufacturing execution systems (electronic batch records).
Experience working in multiple projects.
Technical writing skills.
Technical knowledge of manufacturing systems, methods and procedures, biopharmaceutical manufacturing processes, knowledge of regulatory aspects (cGMP).
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
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.