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Process Engineer-Serialization
at Azzur Group
Raleigh, NC

Process Engineer-Serialization
at Azzur Group
Raleigh, NC

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Description

Job Description

 

Our client, a leader in the Life Science industry, seeks a Process Engineer-Serialization. A successful candidate will be able to

  • Key contributor of Serialization team
  • Assist with developing specifications as needed for equipment / systems
  • Support equipment installation and shakedown of new equipment relevant to manufacturing, packaging and utility systems
  • Provide input to test parameters, process parameters, validation documentation
  • Support documentation generation
  • Support process development for systems and equipment
  • Develop critical parameters needed for follow up validation testing of equipment
  • Perform basic to high-level mathematical calculations to support process development
  • Monitor manufacturing and packaging processes during initial production run to assess any technical process issues.
  • Assist in composing process optimization protocols.
  • Clearly and accurately document activities.
  • Provide input to Master Batch Records (MBRs). (equipment, critical process parameters, in-process tests, etc.)
  • Assist technicians in performing physical testing during the manufacturing and packaging operation (e.g. sieve analysis, tap and bulk density, cap torque testing, etc.).
  • Work with multi-functional team to meet goals and achieve results

Required Experience

  • Serialization experience (Optel)
  • B.S. in Engineering, Pharmacy or Chemistry or related scientific degree.
  • 2+ years in pharmaceutical manufacturing environment or equivalent regulated industry.
  • Basic understanding of pharmaceutical manufacturing and packaging equipment and processes.
  • Basic understanding of the basic principles of technology transfer, process investigations, scale-up, process validation, and optimization of pharmaceutical processes spanning the entire product life-cycle.
  • Basic understanding of applicable SOPs.
  • Basic understanding of safety policies.
  • Safety - Ability to wear Personal Protective Equipment as required. Understands and follows safety procedures and works in a manner to avoid injury to self and co-workers.
  • Regulatory Compliance The ability to work in a regulated environment (FDA, DEA, OSHA, etc.) and strictly follow procedures.
  • Communication Strong and effective verbal and written communication. Ability to read and comprehend detailed written instructions.

Company Description

Our employees are fueled by an entrepreneurial spirit and the desire to make a difference in the lives of our customers, coworkers and our partners. If you’re ready to put in the work, take personal responsibility and test the limits of what’s possible, we’re ready to provide the reward.

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