Upstream Process Engineer

Technical Source

Upstream Process Engineer

Durham, NC
Full Time
Paid
  • Responsibilities

    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.
  • Compensation
    $80,000-$120,000 per year