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Engineer, Facility OR Senior Engineer, Facility

Company: Boehringer Ingelheim
Location: Fremont
Posted on: November 18, 2021

Job Description:

Description:
Engineer, Facility OR Senior Engineer, Facility
The qualified candidate will be hired at the appropriate level commensurate with education/experience.
Engineer, Facility
The Engineer, Facility is responsible to maintain the site utility system and can be the owner of those small utility equipment. This includes but not limited to WFI, CSG, Plant steam, HVAC, clean compressed gases, chiller, building generator and warehouse equipment. He/she will troubleshoot site utilities equipment/process issues, may support/participate/lead site CAPEX/OPEX/continuous improvement projects from feasibility study, equipment/process design, plan, implementation, startup, commissioning, qualification to quality release. He/she might also own change control and participate in deviation/risk assessment activities.
Senior Engineer, Facility
The Facility Senior Engineer is the technical lead and equipment owner on the site utility systems. This includes but not limited to WFI, CSG, Plant steam, HVAC, clean compressed gases, chiller, building generator and warehouse equipment. He/she will troubleshoot site utilities equipment/process issues, support/lead site CAPEX/OPEX/continuous improvement projects from feasibility study, equipment/process design, plan, implementation, startup, commissioning, qualification to quality release. He/she also owns change control and participates/leads in deviation/risk assessment activities.
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.

Engineer, Facility- Duties & Responsibilities\:

  • Responsible for the economic and reliable availability and flexibility of their system. Knowledge about the processes, automation and equipment-specific technology to participate in troubleshooting activities.
  • Technical Analysis\: including mechanical system and technology plant fits, capacity and equipment utilization, value engineering, sustainable design, constructability and assessment of applicable new technologies to balance performance, cost and maintainability
  • Participate (or lead small) CAPEX/OPEX/CI projects
  • Provide risk assessment for new systems and changes to existing systems
  • Write simple project execution plans.
  • Execute startup/commissioning activities (e.g. write commissioning report, review/approve TOPs, create/update/review/approve SOPs).
  • Technical reviews of protocols and periodic monitoring
  • Lead or participate in project team including the supervision of contractors.
  • Provides estimates of resource requirements.
  • Responsible for technical optimization of the field of care.
  • Ensures that the facility equipment, machinery, documentation and technical support meets the compliance, quality and EHS standards.
  • Contributes to, supports, or leads BPE/MPE activities to ensure a continuous optimization process.
  • Own/execute small CAPA, deviation, change control, and risk assessment (quality, business and/or safety).
  • Supports implementation and improvement of best practice of technical standards, procedures.
  • Acts as a member of Global Engineering Biopharmaceuticals and of Global Engineering Boehringer Ingelheim.
  • Participates in peer to peer reviews. Senior Engineer, Facility- Duties & Responsibilities
    • Technical Expertise
      • Experience & knowledgeable with facilities within the following areas\: site utilities system and equipment (i.e. WFI, CSG, Plant steam, HVAC, clean compressed gases, chiller, building generator and etc.), office and amenities, knowledge of commercial/clinical manufacturing and warehouse operations.
      • Manage the life cycle management of the facilities/utilities equipment.
      • Responsible for the economic and reliable availability and flexibility of their system.
      • Expert knowledge of processes, automation and equipment-specific technology to lead in troubleshooting as the Engineering technical lead.
      • Lead/manage technical analysis\: including mechanical system and technology plant fits, capacity and equipment utilization, value engineering, sustainable design, constructibility and assessment of applicable new technologies to balance performance, cost and maintainability.
      • Project Management
        • Lead CAPEX/OPEX/CI projects, including but not limited to\:- Own risk assessment for new systems and changes to existing systems
        • Write/review project execution plans
        • Lead/manage startup/commissioning activities (e.g. approve commissioning report, review/approve TOPs, create/update/review/approve SOPs...)
        • Technical approvers of protocols and periodic monitoring
        • Lead/manage project team including overseeing & providing guidance on contractor activities
        • Provides estimates of resource requirements.
        • Optimization & Compliance
          • Own technical optimization of the field of care.
          • Ensures that the facility equipment, machinery, documentation and technical support meets the compliance, quality and EHS standards.
          • Leads/motivates activities to ensure a continuous optimization process.
          • Own/execute CAPA, deviation, change control, and risk assessment (quality, business and/or safety)
          • Global Engineering
            • Supports implementation and improvement of best practice of technical standards, procedures.
            • Acts as a member of Global Engineering Biopharmaceuticals and of global Engineering Boehringer Ingelheim.
            • Participates in peer to peer reviews.
            • Others
              • Creates curriculum and trains operations/facilities staff as required to ensure production/utilities commences at the desired rate.
              • Ability to manage vendors for the purposes of assessments and certifications.
              • Oversee contractor(s) and provide guidance/approval on activities at site
              • Coach junior engineer(s) Engineer, Facility- Requirements
                • Bachelor--s degree in Engineering from an accredited institution plus five (5) years of related field experience or Master--s degree from an accredited institution in Engineering from accredited plus three (3) year of related field experience
                • Minimum of two (2) years working experience in a GMP manufacturing environment
                • Hands on experience with utilities system/equipment (e.g. WFI, Plant steam, CSG, HVAC, Clean Compressed Gases, Chiller, Building Generator)
                • Knowledge of commercial/clinical manufacturing and warehouse operations.
                • Knowledge of risk assessment, root cause investigation, project startup/commissioning/qualification.
                • Experience with troubleshooting technical issues.
                • Understand compliance requirement on change control, deviation and CAPA.
                • Prior experience overseeing contractor activities. Senior Engineer, Facility- Requirements
                  • Bachelors Degree from an accredited institution in Engineering with eight (8) years of related field experience, Or
                  • Masters Degree from an accredited institution in Engineering with (6) years of related field experience, Or P.E. License
                  • Minimum of four (4) years working experience in a GMP manufacturing environment
                  • Minimum five (5) years and hands on experience with utilities system/equipment
                  • Knowledge of GMP compliance
                  • Technical expertise on utility equipment/system
                  • Recognize safety requirements in manufacturing environment
                  • Equipment hands on experience
                  • Project leadership experience
                  • Excellent oral and written communication skills
                  • Capable to own and lead risk assessment, root cause investigation, project startup/commissioning/qualification.
                  • Expert on troubleshooting technical issues
                  • Owner of change control, deviation and CAPA
                  • Capable to lead projects (CAPEX or CI)
                  • Physical demands/surroundings - works primarily in an office environment. it is 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. 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
                    • This position will require individuals to be fully vaccinated against COVID-19 or have an approved medical or religious accommodation. Click here for more information on the vaccine mandate and COVID-19. Who We Are\:
                      ..... click apply for full job details

Keywords: Boehringer Ingelheim, Fremont , Engineer, Facility OR Senior Engineer, Facility, Engineering , Fremont, California

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