Drug Product Manufacturing Process Engineer I

Company: FUJIFILM Diosynth Biotechnologies
Location: College Station
Posted on: May 14, 2022

Job Description:

The Manufacturing Process Engineer I - is an entry-level position in the manufacturing department in support of the drug product life cycle located at the Texas Bio Manufacturing Facility in College Station, Texas. This position will report directly to the Sr. Manager DP Manufacturing but may also have a functional reporting relationship to a senior colleague on a project to project basis. Works independently, and with colleagues, to provide expertise and assistance for the design, development, standardization and maintenance of an operational filler machines utilized in the aseptic fill for drug product. This person would become the subject matter expert on core manufacturing and operational technologies for the manufacturing unit. Operational biotechnologies include: Isolators and their use in the single use technology, visual inspection and work under aseptic and clean rooms. This position will also require to aseptically gown, create training programs and perform training for manufacturing technicians in the "shop floor" in the unit operation categories. External US Essential Functions:Develop and maintain equipment and unit operation standards and procedures including:

• Develop and deliver effective skill building and training plans for a given operational technology to manufacturing technicians.
• Collaborate with individuals and teams of technicians & managers on self-development plans.
• Develop and assure alignment of training and skill building activities to site business requirements.
• Provide guidance and direction on internal and cross-functional training initiatives. Understand process control and material inputs to ensure capable and acceptable process output. Guide in the selection of components materials for drug product in an aseptic fill. Understand technology operation capabilities, limits and control strategies.
  • Gown and troubleshoot filler machines.
  • Receive clients/or service providers and tour area, equipment and facility
  • Assist in the selection of new technology for Fill/Finish (Filler/Isolators, Inspection booth and inspection machines.
  • Perform proof of concept by operating the machine.
  • Review and/or Approve equipment qualification limits.
  • Review Calibration Tolerances and Approve Out of Tolerance Investigations
  • Represent the manufacturing unit for equipment purchase, new technology and changes to equipment.
  • Lead operational technology standardization, standard batch templates and instruction interfaces and lead continuous improvement for a given technology.
  • Interface with Process Development and Process Science to ensure smooth transfer of processes into the manufacturing plant.
  • Develop and approve procedures and batch records. Required Skills & Abilities:
    • Excellent oral and written communication skills, interpersonal and organizational skills.
    • Strong leadership skills.
    • Ability to gown and train others to perform to cGMP standards.
    • Proficient with Microsoft Office applications and statistical , OpEx and investigational tools
    • Good self-discipline and attention to detail; ability to work under minimal supervision.
    • Must have flexible work hours - must be willing to work outside of normally-scheduled hours as necessary; including opportunities for alternative shift-hours and weekends as required.
    • Experience working in cleanroom environments under sterile or aseptic conditions; must have experience in engineering standards required for this type of operation.
    • Must have good planning skills and must be willing to interface with and guide colleagues in many different roles and functions throughout the manufacturing facilities. Working Conditions & Physical Requirements: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. While performing the duties of this job, the employee is regularly required to:
      • Experience prolonged standing, some bending, stooping, pushing, pulling, reaching above shoulders and stretching.
      • Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.
      • Lift up to 25 pounds frequently and up to 50 pounds, on occasion.
      • Attendance is mandatory. Minimum Qualifications:
        • Bachelor's degree in Science, Engineering or other related field and 3 years of relevant experience;
        • Associate's degree in Science, Engineering, Mechanical/Instrumentation or other related field and 4 years of relevant experience Preferred Qualifications:
          • Experience in trouble shooting on Isolators, robotics and/or filler machines
          • Experience in developing and conducting training
          • Experience with laboratory and or manufacturing instruments/equipment.
          • Previous leadership roles.
          • GMP experience and regulatory audit experience We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state, or local law. If an accommodation to the application process is needed, please email or call .

Keywords: FUJIFILM Diosynth Biotechnologies, College Station , Drug Product Manufacturing Process Engineer I, Other , College Station, Texas