Halo Pharmaceuticals

Calibration Specialist

US-NJ-Whippany
Type
Regular Full-Time

Overview

The Instrumentation (Calibration) Specialist is responsible for technical leadership responsibilities performing calibration/metrology (scheduled and non-scheduled) of all GMP devices, gauges, instruments, transmitters, and sensors on equipment and/or systems within operations which includes, but is not limited to, the aseptic filling line (vial washer, tunnel, filler,), compounding system, component preparation, terminal sterilizer for diluent product, small parts washer /dryer, autoclave/VHP pass thru unit, secondary packaging line, vial labeler, vision inspection machine and clean utilities (Di System, Clean steam system, WFI system). The incumbent interacts with Production, Packaging, QC, QA, Technical services, Maintenance, IT, Materials Management, Product Development and other departments as required. 

Responsibilities

 

The Specialist will calibrate, trouble shoot and / or repair length, mass, volumetric, pressure, thermodynamic, and loop based assets that support manufacturing, facilities, and laboratory processes while maintaining conformance to cGMP and measurement standards.

 Assist with development and maintaining calibration program which includes but is not limited to:

  • Performing calibration activities
  • Maintaining calibration standards and documents
  • Develop and maintain metrics/KPI’s.
  • Vendor/contractor coordination
  • Budget control
  •   Assist supervision during CAPA initiatives and investigations
  • May provide general or direct supervision to non-exempt employees. A portion of the time may be spent performing individual tasks
  • Adhere to cGMPs, SOPs, Batch Record Processing Steps and site safety policies
  • SOP development and review
  • Maintain spare parts inventory on critical Production/Packaging equipment and clean utilities
  • Perform other duties as assigned

 

Other duties as required

 

Qualifications

POSITION QUALIFICATIONS

  • Experienced with data base programs. Ability to create and run queries to produce selective reports.
  • Strong knowledge of MS Excel for reporting.
  • Knowledge of the 7 SI units of measurement
  • Demonstrated effective communicating and interpersonal skills
  • Previous experience working in controlled critical areas (A, B, C, D or ISO5, 7, 8) is preferred
  • Must have strong problem solving skills
  • PLC programming knowledge a plus
  • Ability to read and write English
  • Must be able to gown for entry into controlled classified areas (A, B, C, D or ISO5, 7, 8)

 

EDUCATION:     

  • Associates Degree or  Bachelor’s degree preferred or combination of education and work related experience.
  • ISA or PMEL certification

 

 

EXPERIENCE:

  • Minimum two (2) years of pharmaceutical industry or related experience.
  • Experience with Trackwise Computer Maintenance Management System is highly desirable

 

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