GMP Facility Coordinator

Company: CSL Behring
Location: Pasadena
Posted on: January 14, 2020

Job Description:

About CSLWith operations in 35+ nations and - 22,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!Job DescriptionThe GMP Facility Coordinator will be a key contributor and technical support in team activities associated with maintenance, continuous improvement and capital projects related to the operation and maintenance of the Cell and Gene Therapy Clinical Manufacturing Facility and R&D Laboratories. The ideal candidate will have technical skills in pilot scale manufacturing facility plant/equipment operations, a complete understanding of, and stringent compliance to, GxP, with an understanding of engineering concepts. Education

• BS degree with a concentration in Engineering or Science preferred. Relevant experience may be considered in lieu of degree.Experience
  • At least 2-5 years' experience in pharmaceutical or laboratory environment ideally with exposure to development of new products
  • Understanding of cGMP and FDA regulated environments.
  • Knowledge of and familiarity with other plant operations, such as Manufacturing, QC/QA, etc.would be preferred
  • Excellent computer skills and willingness to learn new programs. Including MS Office, MS Project and MS Visio.Competencies
    • Understanding of Biopharmaceutical and/or Pharmaceutical manufacturing and Quality processes, including GxP validation principles.
    • Understanding of Computer Maintenance Management Systems (CMMS)
    • Knowledge and experience with SAP ERP system. Understanding of Plant Maintenance (PM) management principles preferred
    • Possess excellent interpersonal skills, both verbal and written. Must be able to communicate effectively with all levels of management and staff
    • Strong customer focus with commitment to high quality outcomes
    • Mechanical aptitude and familiarity with engineering drawings and specifications.
    • Understanding of instrument calibration systems and management highly desirable
    • Experience with clean room facilities and practices
    • Awareness of various regulatory guidance's such as PIC/s, FDA, EMEA and ICH
    • Task and team oriented, analytical, organized, detail-oriented, self-motivate and able to multi-task
    • Ability to work in a fast-paced and changing environmentWorking Conditions
      • Ability to lift or carry up to 40 lbs.
      • Ability to stand for prolonged periods of time
      • Frequently required to wear personal protective equipment
      • Occasionally exposed to hazardous chemicals and to blood borne pathogens (under proper safety guidelines)Travel Requirements
        • The role is based in Pasadena with, occasional visits to vendors sites and CSL Behring site as required

Keywords: CSL Behring, Pasadena , GMP Facility Coordinator, Other , Pasadena, Texas