Master MFG Associate, Upstream

Company: Boehringer Ingelheim
Location: Fremont
Posted on: June 22, 2022

Job Description:

Description:Description\: -Executes and coordinates unit operations in Upstream manufacturing as assigned related to the manufacturing of bulk drug substance in a multi-product facility. Performs duties under limited supervision and according to standard operating and manufacturing procedures. Serves as an operations subject matter expert (SME) representing the department during audits, new product introductions, and technical assessments. - - - - - - - - -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\:

• Independently executes complex unit operations including but not limited to batching and inoculation of bioreactors, operation of bioreactors, process monitoring, and harvest operations. Supports equipment and process troubleshooting and implements continuous improvement projects of low to moderate complexity in the production areas. Defines user requirements for new equipment and validation protocols. - -
• Executes independently with adequate training fundamental operations\:
  • CIP/SIP of bioreactors, tanks, and harvest equipment.
  • Media preparation and transfer into tanks and disposables.
  • Cell inoculation and transfer.
  • Daily analytics and maintenance of analytical equipment.
  • May be required to support parts cleaning and weigh and dispense operations.
  • Performs internal support duties including stocking consumables/materials, updating controlled SOP binders, appropriately discarding expired reagents, recognizing and reporting process and equipment anomalies.
  • Documents work according to cGMP and cGDP.
  • Adheres to established regulations and follows cGMP established by site.
  • Reports abnormalities and deviations in a timely and accurate manner.
  • Adheres to safety standards and identifies unsafe situations / habits and escalates appropriately.
  • Maintains production areas according to predefined standards (5s).
  • Maintains own training within compliance and trains other technicians and associates on operations upon completion of trainer qualification. Conducts group trainings on complex topics and scientific principles as needed.
  • Contributes to Quality activities as investigations and area walk-throughs.Requirements\:
    • High school degree plus minimum four (4) year's work experience in GMP regulated industry
    • Associates/Bachelor's degree from an accredited institution or biotechnology vocational training preferred.
    • Four (4) or more years of experience in cGMP regulated industry.
    • Ability to concentrate on detail oriented work in a complex technical setup with a Quality and Right the first time mindset.
    • Strong written and verbal communication skills.
    • Ability to work with computer-based systems and ideally experience with process control systems (e.g. Delta V) and manufacturing execution systems (MES).
    • Ability to read and understand SOPs and work instructions and document work in a written format applying cGMP standards.
    • Ability to work as part of a high performing team and collaborate effectively with staff.
    • Strong working knowledge of biopharmaceutical manufacturing practices, as well as a strong understanding of biologics principles are required.
    • Working in a highly regulated environment following all applicable BI and BI Fremont SOPs, OCPs and BGSs for cGMP, EHS and Compliance policies.
    • Required to work according to given schedules in a 24/7 shift structure and flexibility to adapt working schedule upon prior given notice.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 olderWho 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, including natural hairstyles, hair texture and protective hairstyles; 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.

Keywords: Boehringer Ingelheim, Fremont , Master MFG Associate, Upstream, Other , Fremont, California