• LFB USA - Process Engineer II

    Job Locations US-MA-Framingham
    Job ID
    2018-1327
    # of Openings
    1
    Category
    Manufacturing
    Type
    Full Time
    Company
    LFB USA
  • Overview

    The Process Engineer II works in the Engineering, Validation & Metrology department and provides expert technical support to Commercial Operations at the Charlton, Framingham and Marlborough facilities. The Process Engineer will provide expertise in troubleshooting problems with manufacturing and facilities. The Process Engineer will be responsible for the lifecycle management of various commissioning, qualification, and/or validation facets of LFB USA. In conjunction with other relevant departments, responsible for providing support for troubleshooting problems in manufacturing, specifies, orders and procures equipment used in manufacturing, performs the preparation of validation documentation for processes and equipment, initiates the production of batch documentation used for engineering and cGMP production.

    Responsibilities

    1. Provide technical support to GMP operations in a multi-product upstream clarification plant. Area of focus for this position will be clarification, chromatography, buffer preparation, cleaning, utilities, shipping validation etc.
    2. Provide engineering study and start up support for tech transfer projects, including preparation of document templates, participation and oversight of testing and lead engineering program management activities for such projects
    3. Partner with Manufacturing and Quality organizations in daily operations to maintain the process in a reliable state of control.
    4. Develop process knowledge and ownership.
    5. Provides technical support and analysis for the resolution of deviations, investigations and process issues.
    6. Identify, own and resolve process and equipment related issues proactively.
    7. Lead the proposal, initiation, testing and implementation of minor proposed changes to clarification and or purification processes.
    8. Complete technical investigations and provides on the floor technical expertise.
    9. Generate documents (technical memos and reports, protocols, etc.,) related to process non-conformances.
    10. Technical representative for LFB-USA with third party engineering contractors.
    11. Perform system programming for manufacturing equipment and provide technical support for automated systems.
    12. Participate in the review of processes to achieve cost effectiveness and improved product quality.
    13. Provide troubleshooting expertise for manufacturing of products both internally and externally to the company.Support manufacturing in the investigation of deviations and performs required risk assessments.
    14. Provide technical leadership in process/equipment related investigations.The primary objective is to ensure manufacturing processes are capable, compliant, in control and continuously improved.
    15. Define relevant operational/technical standards and practices
    16. Provide daily on the floor technical support.
    17. Prepare Change Controls, CAPAs and Investigation Reports related to the manufacturing process.

    Qualifications

    Education:     BS degree in Chemical or Process Engineering or Biological or Pharmaceutical Science. MS degree preferred.

    Experience:   MS degree with min 3 years’ experience; or BS degree with min 5 years’ experience in the field of biopharmaceutical manufacturing.

     

    • Good communication skills and experience in a multidisciplinary FDA/GMP environment are required.
    • Hands-on experience in running, developing and troubleshooting protein purification, clarification, UF/DF, TFF, and filtration processes and utilities.
    • Knowledge of large scale biotechnology unit operations, principles of CIP, principles of biochemical engineering,
    • Understanding of compliance and cGMP considerations.
    • Demonstrated commitment to continuous improvement – at the individual, department and organizational levels.
    • Demonstrated strong technical writing and presentation skills.
    • Experience in the scale up and operation of large scale biotechnology processes.
    • Hands-on experience with large scale biotechnology unit operations.
    • Experience in working with cross functional teams in high paced environment.

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed