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Shift timings: 02:00 PM to 10:15 PMThis position is off-shift (2nd) Primary function includes operating manufacturing equipment to produce components or final product. Description: Utilizing knowledge of basic math, drawings. Perform production functions in a Class 100 cleanroom (core) and ...

Job Description

Shift timings: 02:00 PM to 10:15 PM

This position is off-shift (2nd) Primary function includes operating manufacturing equipment to produce components or final product.

Description:

  • Utilizing knowledge of basic math, drawings.
  • Perform production functions in a Class 100 cleanroom (core) and finishing area according to company and departmental SOP’s.
  • Set up and operate production equipment.
  • Utilizes automated equipment and computer hardware and software to accomplish work.
  • Uses testers, fixtures, self-inspection and troubleshooting methods and techniques.
  • Ability to utilize information from sources outside of work group.
  • May participate in a manufacturing/Site Focus Team e.g. Safety, GMP or ESD.
  • Interpersonal skills include demonstrating leadership in a positive and effective way, training peers and cross-training. Must be able to persuade peers and influence work group if needed.
  • Responsible for operating within and maintaining the effectiveness of the Quality Systems.
  • Maintain records to comply with current Good Manufacturing Practices and Standard Operating Procedures.
  • Meeting departmental goals for Quality and Quality of work.
  • Working within the Code of Conduct and maintaining performance standards as communicated by department.

Details:

  • Applies aseptic technique to meet ISO standards
  • Utilizes automated equipment and computer hardware and software to accomplish work.
  • Responsible for all aspects of work order processing including product inspections, documentation, and minor equipment adjustments.
  • Capable of operating complex processing equipment, including set up and troubleshooting experience to make corrections on minor equipment malfunctions
  • Recognizes and corrects problems with machine operations.
  • Perform cleaning of work areas
  • Reads, understands and follows manufacturing documentation and instructions.
  • Operate pallet jacks

Objectives include:

  • Strict adherence to safety guidelines and assures accurate work order documentation.
  • Operates within procedures and product specifications.
  • Maintains product quality and meets production standards.
  • Follows cGMP's, and applicable safety rules.
  • Review of documentation for accuracy and completeness.
  • Responsible for operating within and maintaining the effectiveness of the Quality Systems.
  • Working within the Code of Conduct and maintaining performance standards as communicated by department.

Requirements:

  • Experience in a cGMP environment
  • Ability to apply good aseptic technique and cleanroom behavior
  • Basic math skills, including simple algebra
  • Basic level of mechanical aptitude
  • Good documentation skills
  • Ability to lift / move 30 lbs.
  • Interpersonal skills include demonstrating leadership in a positive and effective way
  • Work with moderate supervision
  • Escalates significant problems to the appropriate level of personnel
  • Ability to multitask and deliver consistent results with above average accuracy
  • Must possess diploma or degree at the Associate or Bachelor level
  • 1+ years’ experience in a sterile operation strongly preferred
  • Experience using Supply Chain Management (SCM) or Process Instruction Sheets within SAP strongly preferred