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Lead Manufacturing Technician

Thermo Fisher Scientific

Thermo Fisher Scientific

Lead Manufacturing Technician

Miami, FL
Full Time
Paid
  • Responsibilities

    How will you make an impact?

    Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon.

    Responsibilities:

    • Commitment to Safety, by following site safety procedures and utilizing safety equipment as required for daily tasks. Ability to document Near Miss reports, safety opportunities, accident reports, etc.

    • Uses batch record instructions, job aids, standard operating procedures, and product specifications to execute production activities.

    • Maintains accurate documentation, records and logs in accordance with FDA (Food and Drug Administration), GMPs (Good Manufacturing Practices) and ISO9000 (International Organization for Standardization).

    • Ability to lead Manufacturing Work Teams in specific processes.

    • Ability to perform minor troubleshooting and problem solving in areas of set-up of equipment and processes.

    • Ability to follow testing and inspection procedures (i.e. visual inspections, in-process, final product attribute).

    • Ability to work in teams to achieve operational goals while being engaged in the process.

    • Makes effective decisions relative to position requirements and include Quality in those decisions.

    • Communicating issues and concerns to supervisor or designee.

    • Some overtime will be required with prior notice to support business needs. Emergency overtime may be required with little notice to ensure operational objectives.

    • Lead Duties:

      • Lead the Tier 1 meetings for manufacturing as part of the tier accountability and communication process.
      • Revise procedures and documents, such as standard operating procedures and manufacturing related documents.
      • Provide performance feedback on manufacturing associates to Supervisor for consideration during performance review process.
      • Review executed batch records for manufacturing to ensure complete and compliant.
      • Enter data for production orders with respect to Goods Issued, Labor Confirmation, TECO, etc.
      • Ability to coordinate the manufacturing schedule for batch execution
      • Support the coordination of activities related to calibration, work orders, validation, etc. into the manufacturing schedule.
      • Ability to support continuous improvement activities such as 5S, standardization of work, process simplification, etc.
      • Ability to support as back-up for other lead associates
    • Powder Manufacturing

      • Ability to set-up and operate powder CIP (Clean in Place) systems
      • Ability to load IBCs (Bins) with raw materials (ROHs) and gross weighings for IBCs (Bins).
      • Ability to perform weighing processes in manual and automated powder packaging processes.
      • Ability to perform all aspects of powder packaging; including material handling, weighing the materials, setting-up of equipment, and operating the equipment (both manual and semi-automated processes).
      • Ability to perform all aspects of Peptone Powder manufacturing; including material handling, weighing the materials, setting-up of equipment, and operating the equipment (both manual and semi-automated processes).
      • Ability to perform all aspects of Cell Culture Powder manufacturing and packaging; including material handling, weighing the materials, setting-up of equipment, and operating the equipment (including the manual, semi-automated processes, and automated processes).
      • Ability to set-up and operate semi-manual and manual powder processing and packaging equipment and process.
      • Ability to set-up and operate automated powder processing and packaging equipment.
    • Liquid Manufacturing

      • Ability to train and qualify in aseptic gowning techniques, as well as, perform all required tasks in an aseptic environment operation
      • Ability to set-up and operate liquid CIP (Clean in Place) systems and sterilization processes.
      • Ability to perform aspects of liquid compounding for liquid product manufacturing.
      • Ability to perform all duties to set-up and operate aseptic liquid filling equipment, including minor trouble-shooting.
      • Ability to set-up, operate and perform the liquid automated bottle packaging line, including minor trouble-shooting.
      • Ability to set-up and perform the liquid bag packaging process.

    Note: Job Description does not include all the tasks assigned to the employee. This is a representation of the area of responsibility. Duties can be added, by Managers/Supervisors, based on operational needs.

  • Qualifications

    Education & Experience

    • Must be able to read proficiently, write legibly, analyze/evaluate charts/graphs, follow simple diagrams, and follow manufacturing and inspection procedures.
    • Must be able to maintain neat, legible, accurate, and complete documentation, records, and logs.
    • Mechanical aptitude is required and to safely operate equipment including major equipment repair, identification of problems, and correcting minor problems.
    • Must be able to focus continuous attention to detailed processes and fairly routine processes.
    • Basic proficiency with PCs (Personal Computers) and basic use of a Windows environment is required. Basic proficiency with Microsoft Office (i.e. Outlook, Word, Excel).
    • An ability to lead and/or train other associates.
    • High School Diploma required.
    • 5 - 7 years of manufacturing experience preferred.

    Working Conditions

    • Exposure to industrial machinery, sharp and moving parts, electrical and other energy sources.
    • Personal Protective Equipment (PPE) required including but not limited to lab coats, hair / beard covers, shoe covers, gloves, ear protection, eye protection and specialized cleanroom suits and head coverings as required.
    • Exposure to fumes and chemicals such as raw materials, cleaners, etc.
    • Infrequent exposure to high frequency noise
    • Ability to lift up to 25 pounds repetitively, and up to 65 pounds non-repetitively
    • Must be able to lift/move 1-5 lbs over 60% of the time, and lift/move 5-25 lbs 40% of the time.
  • Industry
    Biotechnology
  • Fun Fact
    25% of our current revenue is generated from products that didn’t exist 5 years ago.
  • About Us

    As the world’s leader in serving science, Thermo Fisher Scientific's professionals develop critical solutions—and build rewarding careers. They help customers in finding cures for cancer, protecting the environment, making sure food is safe, and so much more. When you #StartYourStory with Thermo Fisher, you are guaranteed meaningful work - both personally and professionally.