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Engineer II/Senior Engineer, MSAT Downstream/Drug Product

Company: Boehringer Ingelheim Pharmaceuticals, Inc
Location: fremont
Posted on: May 3, 2021

Job 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!This is a dual-level posting. Determination as to the level the applicant will be hired in at, will be awarded by the hiring manager based on relevant work history and education. Engineer II Description:The primary purpose of the position is to execute projects, perform complex experiments and analyze complex data in the Downstream and Drug Product Manufacturing Science and Technology (MSAT) group. The position holder occasionally represents MSAT in interactions with customers and collaborators internal and external. The Engineer II must live the BI values and promote a positive work environment for others. Has discretion in tactical execution of process improvement projects, investigations and experiments. Frequently executes complex experiments with sound scientific and engineering principals to resolve problems. The Engineer II frequently executes against specific deliverables developed by the department leadership and occasionally creates proposals to improve operational efficiency. This position may support New Product Introduction and GMP operations in the Disposables Clinical Manufacturing Facility to produce drug substance under GMP/GLP conditions for toxicology and clinical studiesSenior Engineer Description:The primary purpose of the position is to manage project, perform experiments and analyze data in the Downstream (DS) and Drug Product (DP) Manufacturing Science and Technology (MSAT) group. The Senior Engineer must provide technical and scientific expertise to specific areas of responsibility of the DS and DP MSAT group. The position holder must be an effective representative of MSAT in interactions with customers and collaborators internal and external. The Senior Engineer must live the BI values and promote a positive work environment for others.The Senior Engineer frequently leads the design and execution of complex experiments with sound scientific and engineering principals to resolve problems, recognizes and resolves unprecedented problems under minimum guidance and frequently executes against specific deliverables developed by the department leadership. The Senior Engineer creates proposals to improve operational efficiency. The Senior Engineer occasionally serves as Process Science representative on project teams. This position may lead New Product Introduction and GMP operations in the Disposables Clinical Manufacturing Facility to produce drug substance under GMP/GLP conditions for toxicology and clinical studies.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 employeesEngineer II Duties & Responsibilities:This position assists in the robust scale-up and implementation of new Downstream and Drug Product processes and equipment by performing process and design reviews and experimentation on specific aspects of the process. The Engineer II utilizes scale-up experience, facility specific knowledge, and engineering principals to trouble shoot equipment and processes.This position assists in the root cause determination of process related deviations in the Downstream and Drug Product areas in a timely and conclusive manner. The Engineer II works with the MSAT team to resolve complex problems and deviations using experience and the efficient application of scientific methodology and technical reasoning. This position frequently executes complex experiments and performs complex data analysis to resolve specific deviation questions, prepares technical reports and occasionally proposes comprehensive process solutions and improvements.This position participates in training and development opportunities in order to gain an understanding of standards of practice, process science and departmental policies. Provides comprehensive trainings to other scientists/engineersThis position independently executes Initial Facility Fit assessment subtasks for the Downstream and Drug Product portions of the GMP Manufacturing facilities.This position identifies and proposes continuous process improvements to management. The incumbent independently executes process and procedural changes to improve Downstream and Drug Product Manufacturing process performance, robustness, productivity, safety and efficiency.This position identifies and proposes continuous process improvements to management. The incumbent independently executes process and procedural changes to improve Downstream and Drug Product Manufacturing process performance, robustness, productivity, safety and efficiency.This position independently executes innovation and technology projects and contributes to a stronger IP position for BI. This position supports establishing state-of-the-art Downstream and Drug Product technologies for MSAT as well as supporting Downstream and Drug Product manufacturing facility and production equipment modifications needed to maintain state-of-the-art production.This position executes specific deliverables for the design of new Purification and Drug Product equipment and facility modifications/expansions independently. The Engineer II applies engineering principals and experience to optimize facility and equipment design. Senior Engineer Duties & Responsibilities: This position executes and occasionally plans the robust scale-up and implementation of new Downstream and Drug Product manufacturing processes and equipment by performing process design reviews and experimentation on specific aspects of the process. The Senior Engineer utilizes scale-up experience, facility specific knowledge and engineering principals to trouble shoot equipment and processes; anticipate potential problems and propose risk mitigations and proactive solutions.This position executes and occasionally develops plans independently to determine the root cause of process related deviations in the Downstream and drug product areas in a timely and conclusive manner. The Senior Engineer works with the MSAT team to resolve complex problems and deviations using experience and efficient application of scientific methodology and technical reasoning. This position designs and executes complex experiments to resolve specific deviation questions, prepares technical reports and proposes comprehensive process solutions and improvements. The Senior Engineer effectively communicates investigational designs, results and recommendations to internal teams and customers.This position participates in training and development opportunities in order to gain an understanding of standards of practice, process science and departmental policies. Provides comprehensive training and guidance to other scientists.This position frequently executes and occasionally leads Initial Facility Fit assessment subtasks for the Downstream and Drug Product portions of the GMP Manufacturing facilities.This position identifies and proposes continuous process improvements to management. The incumbent frequently executes and occasionally leads complex process and procedural changes to improve Downstream and Drug Product manufacturing process performance, robustness, productivity, safety and efficiency. This position executes and occasionally develops plans for continuous improvement in innovation and technology and contributes to a stronger IP position for BI. This position supports establishing state-of-the-art Downstream and Drug Product technologies for MSAT as well as supporting Downstream and Drug Product manufacturing facility and production equipment modifications needed to maintain state-of-the-art production. This position plans and executes specific deliverables for new Downstream/Drug Product equipment and facility modification/expansion. The Senior Engineer applies engineering principals and experience to optimize facility and equipment design..... click apply for full job details

Keywords: Boehringer Ingelheim Pharmaceuticals, Inc, Fremont , Engineer II/Senior Engineer, MSAT Downstream/Drug Product, Other , fremont, California

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