Boehringer Ingelheim Engineer II/Senior Engineer, MSAT Upstream in FREMONT, California

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.

Description:

Boehringer Ingelheim Fremont Inc. - Boehringer Ingelheim is one of the world's leading biopharmaceutical contract development and manufacturing organizations. Boehringer Ingelheim Fremont Inc. is currently searching for a talented and innovative Engineer/Senior Engineer to join the MSAT (Manufacturing Science & Technology) group in the Process Science department at Boehringer Ingelheim’s Fremont, CA location. There are several roles open in this group, but the identified Candidate will be hired at the level commensurate with education and years of experience.

The primary purpose of the Engineer II position is to execute projects, perform complex experiments and analyze complex data in the Upstream 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 studies.

The primary purpose of the Senior Engineer position is to manage project, perform experiments and analyze data in the Upstream (US) Manufacturing Science and Technology (MSAT) group. The Senior Engineer must provide technical and scientific expertise to specific areas of responsibility of the US 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 also a 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 employees

Duties & Responsibilities:

  • This position executes and occasionally leads the robust scale-up and implementation of new Upstream 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 troubleshoot equipment and processes; anticipate potential problems and propose risk mitigations and proactive solutions. This position executes and occasionally leads the robust scale-up and implementation of new Upstream 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 Upstream 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 subtask for the Upstream 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 Upstream 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 Upstream technologies for MSAT as well as supporting Upstream manufacturing facility and production equipment modifications needed to maintain state-of-the-art production.

  • This position plans and executes specific deliverables for new Upstream equipment and facility modification and expansion. The Senior Engineer applies engineering principals and experience to optimize facility and equipment design.

Engineer II Requirements & Desired Skills, Experience and Abilities:

  • At least Bachelor’s degree from an accredited institution with four plus (4+) years’ experience OR Master’s degree from an accredited institution with two plus (2+) years’ experience OR PhD from an accredited institution with zero (0) years of industry experience and statistical analysis skills

  • Technical knowledge in process science area

  • Technical knowledge of Upstream manufacturing principles, techniques and equipment

  • Understanding of validation of biopharmaceutical facilities, equipment and process

  • Drives continuous process improvements

  • Ability to lead effectively in a matrixed organization

  • Proven skills building and maintaining productive relationships with organizational partners such as manufacturing and quality

  • Experience/Expertise in a scientific discipline (chemical/biochemical engineering, biopharmaceuticals, biotechnology, molecular biology, biochemistry, cell biology

  • Six Sigma experiences will be a plus

Senior Engineer Requirements & Desired Skills, Experience and Abilities:

  • At least Bachelor’s degree from an accredited institution with five plus (5+) OR Master’s from an accredited institution with three plus (3+) OR PhD from an accredited institution with zero plus (0+) years of industry experience, statistical analysis skills.

  • Project management experience

  • Six Sigma experiences will be a plus

  • Technical knowledge in process science area

  • Technical knowledge of Upstream manufacturing principles, techniques and equipment

  • Understanding of validation of biopharmaceutical facilities, equipment and process

  • Drives continuous process improvements

  • Ability to lead effectively in a matrixed organization

  • Proven skills building and maintaining productive relationships with organizational partners such as manufacturing and quality

  • This position may be accountable to answer process related questions of regulators. The position must have expert knowledge of upstream processes and related manufacturing equipment and facility attributes for the BIFI site.

  • Experience/Expertise in a scientific discipline (chemical/biochemical engineering, biopharmaceuticals, biotechnology, molecular biology, biochemistry, cell biology)

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

Our Culture:

Boehringer Ingelheim is one of the world’s top 20 pharmaceutical companies and operates globally with approximately 50,000 employees. Since our founding in 1885, the company has remained family-owned and today we are committed to creating value through innovation in three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. Since we are privately held, we have the ability to take an innovative, long-term view. Our focus is on scientific discoveries and the introduction of truly novel medicines that improve lives and provide valuable services and support to patients and their families. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. We are also deeply committed to our communities and our employees create and engage in programs that strengthen the neighborhoods where we live and work. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA, Inc., Merial Barceloneta, LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment verifications and drug screenings.

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Organization: US-BI Fremont

Title: Engineer II/Senior Engineer, MSAT Upstream

Location: Americas-United States-CA-Fremont

Requisition ID: 175038