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Engineer, Process Engineering (Purification)

Company: Roche
Location: Vacaville
Posted on: September 18, 2022

Job Description:

At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity, and diversity. We believe every employee makes a difference. We are passionate about transforming patients' lives. We are courageous in both decision and action, we believe that good business means a better world.

The focus of the Vacaville Operations Facility is Drug Substance bulk manufacturing. We have a passion for science, technology, innovation, professional development, and diversity and inclusion. We are also deeply respected for our unique and special culture; one that centers around the people we attract and hire. Our Pharma vision is to have a greater overall patient benefit and impact. This focus includes personalized healthcare, designing the processes with the patient in mind, and improving their quality of life. We hope you consider joining our team and being a part of one of the largest biotechnology facilities in the world!

Job Summary:

The Manufacturing Sciences Purification (MS Pur) group is dedicated to providing scientific and technical support to Vacaville drug substance manufacturing operations, from harvest through formulation and storage. The MS Pur group works in collaboration with Manufacturing, Process Development, Quality, and other technical and business functions in order to ensure efficient and safe drug substance manufacturing processes for the production of multiple recombinant proteins. MS Pur is responsible for receiving new processes from Process Development or other manufacturing sites, process monitoring and analysis, process performance troubleshooting, as well as establishment and maintenance of the process validated state and ongoing process improvement.

The open position is for purification engineer/manufacturing technical specialist within the MS Pur group, with responsibility for specifying manufacturing process requirements, monitoring and analysis of manufacturing process data, execution of full-scale process validation and technical oversight of scale down (laboratory) experiments, and analyzing process and facility capabilities to identify improvement opportunities.

Specific responsibilities for this position will include (but are not limited to):

  • Provide purification technical leadership to support commercial drug substance production at Genentech Vacaville, including specification of process requirements, monitoring, analysis, troubleshooting, and maintenance of the validated state of the manufacturing process.
  • Provide a science-based approach for resolution of deviations, investigations, and process issues through analysis of historical data and scale-down studies.
  • Authoring and/or review technical documents related to technology transfer, process monitoring, at-scale or scale-down studies, annual product reviews, and non-conformance (deviations/investigations) to support process transfer and ongoing manufacturing.
  • Contribute to the design, formulation, review, and implementation of purification manufacturing formulae, SOPs, and associated process documents.
  • Lead or participate in process validation and technology transfer activities, as well as health authority prior approval inspection for commercial license and product launch.
  • Participate in the design and technical oversight of laboratory experiments in support of plant operations, troubleshooting, process transfer, process improvement and process understanding.
  • Participate or lead new technology evaluation. Contribute to the supporting data necessary for change implementation. Interact with planning and manufacturing groups to execute process improvement projects.
  • Serve as site representative on cross-functional teams including global unit operation teams, technology transfer teams, and global process validation team to define and implement product-focused strategic initiatives at Vacaville.
  • Collaborate with manufacturing, quality, and regulatory organizations to establish a reliable state of manufacturing process control.
  • Maintain full working knowledge of principles and theories, as well as advancing understanding and state of control in commercial manufacturing process.
  • Keep abreast of industry best practices, and evaluate potential application within organization, as applicable.

    In addition to core responsibilities, the successful candidate may be asked to perform additional technical assignments.

    Job Requirements:

    • BS or higher degree in Chemical or Biochemical Engineering.
    • Minimum of 5 years for B.S (or 2 years for MS or 0 years for PhD) work experience in cGMP biopharmaceutical production setting (process development and/or manufacturing technical support)
    • Experience in large-scale biopharmaceutical manufacturing process, as applied to purification processes (harvest, chromatography, filtration and ultrafiltration diafiltration operations) - including scale-up/scale-down, principles of biochemical engineering, and process data analysis
    • Full understanding of cGMP requirements
    • Proficiency in statistical and multivariate data analysis techniques
    • Self-motivated, able to work independently as well as in teams. Excellent organization and communication skills (both written and verbal)
    • Demonstrated experience in leading cross-functional teams responsible for the implementation of technical changes / process improvements
    • Ability to exercise independent judgment and discretion regarding matters of importance and to problem solve in creative ways. Excellent written and verbal communication skills
    • Ability to support international meetings within the Roche network (early morning / late evening)
    • Ability to provide urgent process troubleshooting support for cross-functional teams (off hours as needed)

      The ideal candidate will have a general knowledge of the underlying scientific principles applied to the development and manufacture of biopharmaceuticals, and a keen interest in purification bioprocess operations. Proficiency in data acquisition and analysis techniques and a willingness to learn new techniques is desired. Knowledge of the following software is desirable: OSI PI (and associated client tools), ORACLE, R, Visual Basic, SAS JMP.

      Relocation has been budgeted/approved for this position.

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      Who we are

      A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

      Unless entitled to a reasonable accommodation under applicable law, employees are required to be fully vaccinated against COVID-19 in accordance with customer requirements, the company's health and safety obligations and/or applicable law or guidelines.

      Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We're focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.

      Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status. For more information about equal employment opportunity, visit our Genentech Careers Homepage.

      Job Level:
      Individual contributor

Keywords: Roche, Vacaville , Engineer, Process Engineering (Purification), Engineering , Vacaville, California

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