• Cambrex Corporation
  • Whippany , NJ
  • Healthcare - Allied Health
  • Full-Time

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Sterile Technician Location Whippany, NJ, USA Department Packaging Apply now

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Overview

The 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.
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Associated topics: lab, medical technologist, mls, mlt, sample collection, technician, technician iii, technician iv, technologist, testing

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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