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Principal Engineer, Engineering

Company: Boehringer Ingelheim
Location: Fremont
Posted on: January 16, 2022

Job Description:

The Principal Engineer is the Engineering technical lead on the Bulk Drug Substance (BDS), Drug Product (DP), Process Science (PS) or Utility systems. This includes but is not limited to Upstream and Downstream BDS, Filling and Packaging equipment, and Utility Systems. Will serve as the SME leading the troubleshooting of equipment/process/utility issues for CAPEX/OPEX/continuous improvement projects from feasibility study through design/C&Q/handover and throughout the equipment life-cycle. Will lead Process Technology Transfer / Business Practices or Programs that involved cross site support. Will own change control and participate in deviation/risk assessment activities. Will manage medium to large in size and complexity equipment and/or utility related projects. Is expected to guide and mentor junior engineers in their role of system owners for Process equipment and/or utility systems (out of tolerance events, deviations, etc. Represents engineering discipline during internal and external audits.
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\:
Technical Expertise

  • Proven experience of managing medium to large projects (Process Technology Transfer or Business Programs with cross site involvement) for both upstream and downstream production areas, Filling and Packaging areas or Utility systems
  • Possess Business acumen and applies negotiation skills in the justification and prioritization of projects.
  • Uses expert knowledge to assist in guiding and supporting less experienced engineers in a mentoring role, during troubleshooting activities
  • Technical Analysis\: Is a self-starter and leads in technology plant fit, capacity and equipment utilization, value engineering, sustainable design, constructability and assessment of applicable new technologies to balance performance, cost and maintainability. Is actively involved and participate in an industrial organization (e.g. ISPE or ASME)
  • As the system owner, understand the impact of any equipment issues/failure to the end user. Take accountability to communicate and support the end user for any mitigation/transition plan to protect the product/process that is impacted. Develop predictive process monitoring system for critical equipmentProject Management
    • Interacts globally with multiple cross-functional areas to evaluate new technologies and their applicability to the site and processes
    • Manage/Lead/Participate in the largest and most complex CAPEX/OPEX/CI projects at the Fremont site including CapEx projects up to -$30M and leading teams of up to 10-15 individuals in a matrix environment
    • Acts as the principal consultant during pre-feasibility/feasibility study and into subsequent design phases
    • Provide expertise and expert knowledge developing project execution plans
    • Lead/manage a project team during all project phases (feasibility through startup/commissioning activities)
    • Approvers of multiple complex documents/protocols/periodic monitoring that may be used in regulatory environments.
    • Provides detail estimates/schedules to support plans and manages external resources. Defines work scope and supervise external contractors that provides services of supporting areas / projects.Optimization & Compliance
      • Responsible for technical optimization of the field of care. Investigates and analyzes customer opportunities for improvement. Design, recommends and implements improvement suggestions.
      • Ensures that the process equipment, machinery, documentation and technical support meets the compliance, quality and EHS standards. Takes ownership to correct/improve if opportunities are found.
      • Drive BPE/MPE activities to ensure a continuous optimization process. Drives activities to accomplish site goals.
      • Lead/execute CAPA, deviation, change control, and risk assessment (quality, business and/or safety) for activities up to initial qualification/handover.Global Engineering
        • Leads and mentors less experience engineers in implementation and improvement of best practice of technical standards, procedures. Consults and communicates experiences with external industrial organizations (ISPE or ASME)
        • Acts as a member of Global Engineering Biopharmaceuticals and of Global Engineering Boehringer Ingelheim.
        • Participate in peer reviews
        • Common project documentation standards. GEN project results, Leads and manages changes to BIFI site Engineering Standards and SpecificationsOthers
          • Creates curriculum and trains operations/facilities staff as required to ensure production/utilities commences at the desired rate.
          • Programs with cross site involvement) for both upstream and downstream production areas, Filling and Packaging areas or Utility Systems.
          • Ability to manage vendors for the purposes of assessments and certifications.
          • Train end user(s) on proper process monitoring and/or respond.
          • Mentors less experience engineer(s) and/or cross functional team members.Requirements\:
            • Bachelor degree from an accredited institution in Engineering, plus twelve (12) years of related field experience; or Master degree from an accredited institution in Engineering, plus ten (10) years of related field experience; or P.E. License
            • Minimum six (6) years of CAPEX Project leadership experience
            • Minimum of six (6) years working experience in a GMP manufacturing environment
            • Minimum six (6) years and hands on experience with utilities system/equipment
            • Capable to own and lead risk assessment, root cause investigation, project startup / commissioning / qualification
            • Expert and Mentors Junior engineer(s) on troubleshooting technical issues
            • Owner of change control, deviation and CAPA
            • Excellent oral and written communication skills
            • Ability to coach/mentor junior engineer(s) and/or other cross functional team members
            • Knowledge and Coaches GMP compliance
            • Technical expertise on more than one utility equipment / system. Preference to be a technical lead in the entire Upstream / Downstream / Utility area with exposure to other areas / systems
            • Recognizes safety requirements in manufacturing environment
            • Equipment hands on experience
            • Proven experience of managing medium to large projects (Process Technology Transfer or BusinessPhysical demands/surroundings - works primarily in an office environment. Required to be on the process floor as necessary to perform work outlined in this profile. Some domestic and international travel may be required.Visual Demands - must be able to read and see clearly with or without correction lens.Attendance/schedule - attendance requirements are based on general attendance policies and the needs of the business as set forth by direct managerEligibility 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.Who 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 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.
                • I-SF1

Keywords: Boehringer Ingelheim, Fremont , Principal Engineer, Engineering, Engineering , Fremont, California

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