B. Braun

  • Process Engineer

    Job Locations US-CA-Irvine
    Requisition ID
    2018-13311
    Company
    B. Braun Medical Inc
    # of Openings
    1
    Category
    Engineering
    Position Type
    Regular Full-Time
    Shift
    8:00am - 5:00pm
    Site
    Irvine, CA
  • Overview

    With a nationwide sales team and several manufacturing locations, B. Braun Medical has become a leading full-line supplier of healthcare products and services in the U.S. The company is committed to delivering innovative products and services with unmatched quality, superior technology, and cost-effectiveness, while maintaining environmental responsibility. Through its "Sharing Expertise®" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. B. Braun employs over 4,500 people in the USA. B. Braun Medical Inc. began its operations in the USA in 1957. Initially, the company manufactured and sold disposable plastic syringes. During the 1980s and early 1990s, the company undertook several expansions and enlarged its product line of disposable medical devices. With the acquisition of McGaw, Inc. in 1997, including Central Admixture Pharmacy Services, Inc. (CAPS®), B. Braun dramatically broadened its product lines and services to U.S. customers.

     

    U.S. Facilities and Operations:

     

    Supporting product sales are a network of nationwide marketing and manufacturing locations. Bethlehem, Pennsylvania, is home to the U.S. Corporate Headquarters along with the marketing offices of the Hospital, Outpatient Markets (OPM), Renal Therapies, Vascular Interventional, International, and OEM Divisions. Central Admixture Pharmacy Services, Inc. (CAPS®) is also managed from this location. The nearby Allentown, Pennsylvania, facility manufactures Needle-free products, IV Safety Catheters, Anesthesia Systems, Introducers, Pharmacy Admixture products. Vascular products including Right Heart Catheters and Interventional Accessories are also manufactured in Allentown. The Irvine, California facility produces IV Solutions, Basic and Specialty Nutrition, Drug Delivery, and BTC products. Infusion Pump Systems are manufactured in Carrollton, Texas and IV administration and IV and Irrigation sets are produced in the Dominican Republic.

    Responsibilities

    Position Summary:

     

    Responsible for functioning as a Process Engineer, individual contributor and subject matter expert for processes, planning, testing and troubleshooting. Provide process engineering expertise toward the design, development, installation, evaluation, startup, verification, maintenance, sustainability, and optimization of process systems and equipment. Demonstrate process engineering expertise within the engineering field while working across a variety of functional groups that are directly involved with capital project life cycles and site operations. 

     

    Responsibilities: Essential Duties

    • Analyze existing processes, procedures and equipment to identify areas of improvement and recommend solutions to optimize systems.
    • Promote strategies for efficiency improvements, lead/support implementation of organization process improvement initiatives and evaluate results.
    • Define and document site standards collaborate with Engineering and Technology Management to institutionalize standards.
    • Draft, edit and update SOPs as necessary to respond to resolution plans to support new processes and equipment.
    • Collect data, provide analysis and proactively identify variances to forecast to assist in developing strategies to improve performance and reduce cost.
    • May be involved in forecasting and analyzing budgets and monitoring of expenditures versus budget, ensuring that expenses are charged to the appropriate cost center for accurate reporting purposes.
    • Assist with training and auditing as appropriate.
    • Prepare Request for Capital Investments including project description, schedule and costs.
    • Supervise and direct contract personnel and outside vendors in the performance of contracted services.
    • Provide leadership and guidance to subordinates within the Engineering organization.
    • Supervise subordinate Engineer(s) and all levels of Engineering.
    • Aides/Technicians on activities related to projects.
    • Provide direction and technical decision making for management involving capital asset purchases and expenses for projects and/or strategic initiatives involving up to $5MM (capital/expense/revenue potentials).
    • Prepare and present technical investigative reports to site leadership.
    • Moderate to high degree of both internal and external personnel interfaces.
    • Supporting/contributing role for other engineering functions.
    • Must have strong problem solving and analytical skills with the ability to produce results with minimal supervision.
    • Must be a team player, detail oriented and be able to function effectively in a cross-functional team environment.
    • Perform other duties as assigned.

    Expertise: Knowledge & Skills

    • Strong aptitude for operations and controls of manufacturing equipment and processes.
    • Ability to prepare system user requirements necessary to achieve process output quality and/or GMP regulatory compliance, and to function and be maintained in a qualified state.
    • Knowledge of product/process requirements including regulatory, design, operational and performance.
    • Understanding of Critical Process Parameters (CPPs) and other process conditions needed to reliably manufacture product which consistently meets its Critical Quality Attributes (CQAs).
    • Ability to prepare process descriptions that meet defined system requirements for applicable systems.
    • Ability to perform environmental assessments to identify potential process risks. Working knowledge to perform and provide oversight of operational modeling to simulate process capabilities. Ability to perform material handling assessments.
    • Working knowledge of dispensing, solution preparation and delivery, clean-in-place, water pre-treatment and purified water, and associated automation systems.
    • Ability to perform material balancing and volumetric estimates to define process materials that enter and exit the process.
    • Ability to perform cycle time and production campaigns analysis to define the basis for anticipated manufacturing throughput.
    • Ability to perform safety reviews for facilities and processes using industry standard methodology (e.g. Process Hazard Analysis, Hazard and Operability Study, etc.).
    • Ability to develop and analyze histograms for designing water generation, distribution and storage systems.
    • Leading the development and management of Process Flow Diagrams (PFDs) and Piping and Instrumentation Diagrams (P&IDs) throughout process life cycles.
    • Working knowledge of Federal Food and Drug Administration (FDA), OSHA and Good Manufacturing Practices (GMP) requirements.
    • Use a broad range of software used in the Pharmaceutical industry (e.g. MS Office applications, MS Project, MS Visio, AutoCAD, SAP, etc.).
    • Ability to write capital requests, reports, business correspondence, and procedure manuals.
    • Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Strong communication skills, both verbal and written, commensurable with dealing with senior level management.
    • Ability to define problems, collect data, establish facts, and draw valid conclusions.
    • Work independently and as a team member.
    • May be required to work or be assigned to a different shift as needed.
    • Strong aptitude in statistics.
    • Strong aptitude in creating process failure mode and effects analysis (PFMEA).
    • Strong aptitude in creation and execution of design of experiment (DOE).

    Qualifications

    Expertise: Qualifications - Experience/Training/Education/Etc.

     

    Required:

    • 4-6  years related experience
    • Bachelor’s degree in related field required

    Desired:

    • Master’s degree in related field preferred
    • Applicable industry certification preferred

     

    While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. 

     

     

    Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com Equal Opportunity Employer Minorities /Women/ Veterans/Disabled.

    Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

    Other

    Responsibilities: Other Duties:

     

    The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.

    Physical Demands:

    • The employee must occasionally lift and/or move up to 30 pounds.

    The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

    Work Environment:

    The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.

     

    IN2017

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