Cambrex

  • Sterile Technician

    Job Location US-NJ-Whippany
    Type
    Regular Full-Time
  • Overview

    The Aseptic (Sterile) Technician is responsible for performing routine cleaning and batch preparation for processes related to bulk formulation, filling. This is a 2nd shift position (3pm-11:30pm).

    Responsibilities

    • Performs Room and Equipment inspections and completes all pertinent documentation.
    • Clearly and accurately completes all required GMP documentation.
    • Follows Standard Operating Procedures, Safety Policies, and current Good Manufacturing Practices to ensure operating in a compliant manner.
    • Works with the Quality Group  to ensure processes and products are in compliance with Standard Operating Procedures  and current Good Manufacturing Practices
    • Participates in all aspects of cleaning and preparation for Sterile Manufacturing/processes.
    • Set-up of key manufacturing equipment: including (but not limited to) batch processors, isolators, VHP generators, autoclave, fillers, steam kettles, CIP/SIP skid, etc.
    • Working inside cleanroom suites for several hours at a time.
    • Technical comprehension of mechanical functions and controls for batch preparation.
    • Maintains and understands sterile manufacturing principles
    • Understand the process flow and step by step requirements for manufacturing
    • Cleans equipment and facilities including Class A, B and C clean rooms per approved procedures
    • Accurately completes batch record documentation, all appropriate logbook entries, and GMP documentation
    • Maintains equipment, change parts, and supplies inventories by checking stock to determine inventory level; anticipates needed equipment, parts, and supplies.
    • Qualified for work in the aseptic processing areas via gown certification
    • Comprehends and adheres to all pertinent Health and Safety Regulations, Policies and Procedures.
    • Comprehends and adheres to all cGMPs and other Regulatory requirements.
    • Comprehends and adheres to all related SOPs as well as Batch Records and Protocols.
    • Completes all required Training activities.
    • Other duties as assigned

    Qualifications

    • May be required to move materials weighing up to 25 lbs
    • Maybe required to move about the facility
    • May be required to remain in an upright position for extended periods of time
    • May be required to work day or evening shifts as needed
    • Required to use all approved and issued Personal Protective Equipment as directed by policy and procedure
    • Requires manual dexterity

     

    EDUCATION

    • High School Diploma or equivalent.
    • Computer literacy and solid communication skills (in English) are a must.
    • Must demonstrate Basic Math skills.

     

    EXPERIENCE

    • 3+ years working in pharmaceutical manufacturing environment.
    • Solid understanding of cGMP practices and concepts.
    • Mechanically inclined candidates are preferred.

     

    Options

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