Upstream Process Engineer Job at Technical Source, Durham, NC

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  • Technical Source
  • Durham, NC

Job Description

Technical Source is seeking an experienced Senior Manufacturing Engineer for a leading pharmaceutical manufacturing client in RTP. The ideal candidate will have a strong background in upstream process equipment engineering, with a focus on ensuring compliance with manufacturing processes.

Responsibilities of the Senior Manufacturing Engineer include:

  • Troubleshoot and improve process equipment systems in manufacturing.
  • Lead process equipment-related projects, including technology transfers, capital projects, and system modifications.
  • Update preventative maintenance job plans, equipment standards, drawings, and specifications.
  • Provide technical input and guidance for equipment validation and change controls in Tech Transfer efforts.
  • Author and approve workflows for equipment/automation-related changes (change controls, deviations, CAPAs) and attend related meetings.
  • Manage the development and execution of process equipment and cleaning validation protocols, including floor support during startup and commissioning.
  • Collaborate on Factory Acceptance Testing (FAT) and equipment commissioning.
  • Support health authority inspections (e.g., FDA) by presenting engineering and validation practices.

Qualifications of the Senior Manufacturing Engineer  include:

  • Bachelor’s degree or higher in Engineering
  • Minimum of 4 years of experience in process equipment engineering
  • Proficiency in GMP regulations and guidelines related to process equipment.
  • Strong analytical, problem-solving, and project management skills.
  • Excellent organizational and communication skills.

Additional Qualifications:

  • Willing to submit to a background check
  • Willing to submit to drug screen

Compensation for the Senior Manufacturing Engineer includes:

  • Salary: $80,000-$120,000 based on experience and qualifications.
  • Benefits: Comprehensive package including medical, dental, and vision coverage.
  • Note: No Corp to Corp or Visa sponsorships currently.

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