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Clinical Manufacturing Process Development Engineer

Company: Bayer
Location: Berkeley
Posted on: January 7, 2022

Job Description:

At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining -impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice.

Clinical Manufacturing Process Development Engineer


The primary responsibilities of this role, Clinical Manufacturing Process Development Engineer, are to:

  • Coordinate with maintenance to manage routine process equipment PMs and calibrations, changeover PMs and calibrations, plant shutdown activities, and repairs;
  • Create, review and/or approve PM and calibration task lists and operational Standard Operating Procedure (SOPs) as needed;
  • Exercise sound technical judgment to solve a wide range of complex scientific and development problems, identify technology gaps and make recommendations to management;
  • Perform troubleshooting of process equipment without assistance, be available to respond to any process equipment emergencies (on-call) in clinical manufacturing;
  • Lead process improvement projects by applying Certified Good Manufacturing Practice (cGMP) and engineering standards for both upstream and downstream processes;
  • Interpret and communicate effectively complex scientific and development findings and recommendations in one-on-one discussions or cross functional meetings;
  • Provide effective leadership including individual goal setting/performance reviews, manage the development of employees, recognize and appreciate employee contributions, mitigate conflict and communication problems, plan and facilitate team activities, select personnel and motivate members of the functional area, support workforce diversity, quality and safety and support supervisors in the management of their employees/department which support achievement of individual/department/business objectives.


    Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:

    Required Qualifications:

    • Bachelor of Science in Chemical or Mechanical or Biological Engineering with at least 10 years of relevant experience OR a Master of Science with at least eight years of relevant experience OR a Ph.D. with at least four years of relevant experience OR an equivalent combination of education and experience;
    • Working knowledge of current standards and best practices for Good Manufacturing Practices (GMP) equipment design;
    • Knowledge of upstream and downstream processes and equipment and utilities for the manufacturing of MABs;
    • Working knowledge of process instrumentation and PLC's;
    • Demonstrate ability to independently troubleshoot problems using engineering first principles;
    • Ability to manage customers and contractors to complete projects on time;
    • Ability to identify gaps in technology and operational systems and implement new technologies and/or novel procedures to resolve them;
    • Excellent verbal and written communication skills including technical writing and technical presentations;
    • Good working knowledge of Microsoft Word, Excel, Powerpoint, Teams, Projects, Visio and Access;
    • Relocation assistance is available.


      Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Science for a better life, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer.
      To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

      Bayer is an Equal Opportunity Employer/Disabled/Veterans

      Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.
      IMPORTANT NOTE for POTENTIAL US CANDIDATES: Bayer active employees are required to disclose their vaccination status and if fully vaccinated, provide proof of vaccination status before participating in approved activities for fully vaccinated employees. Bayer defines fully vaccinated in alignment with CDC which is two weeks after completing the two-dose vaccine regimen or two weeks after completing the one-dose regimen. Additionally, if candidates are invited on site as visitors for in person interviews, they must provide proof of being vaccinated and comply with all safety protocols. Location: United States : California : Berkeley Division: Pharmaceuticals Reference Code: 367842 Contact Us Email:

      Job Segment: Process Engineer, Clinic, Industrial, Manufacturing Engineer, Engineering, Healthcare, Manufacturing

Keywords: Bayer, Berkeley , Clinical Manufacturing Process Development Engineer, Healthcare , Berkeley, California

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