Halo Pharmaceuticals

Sterile (Aseptic) Technician - 2nd Shift

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

Overview

The Aseptic Technician is responsible for performing routine cleaning and batch preparation for processes related to bulk formulation, filling. This is a 2nd shift position.

Responsibilities

  • Reports to packaging management.  
  • 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.
  • Required to use all approved and issued Personal Protective Equipment as directed by policy and procedure.
  • Completes all required Training activities.
  • Clearly and accurately completes all required GMP documentation.
  • Perform Room and Equipment inspections and completes all pertinent documentation.
  • Manual Dexterity is required.
  • Follow Standard Operating Procedures, Safety Policies, and current Good Manufacturing Practices to ensure operating within a compliant manner.
  • Work with the Quality Group  to ensure processes and products are in compliance with Standard Operating Procedures  and current Good Manufacturing Practices
  • Participate 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.
  • Cleaning equipment and facilities including Class A, B and C clean rooms per approved procedures
  • Accurately complete batch record documentation, all appropriate logbook entries, and GMP documentation
  • Maintains equipment, change parts, and supplies inventories by checking stock to determine inventory level; anticipating needed equipment, parts, and supplies.
  • May be required to work either day or evening shifts as needed
  • Qualified for work in the aseptic processing areas via gown certification
  • Must be able to lift 25lbs
  • Other duties as assigned

Qualifications

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.

 

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