Process Engineer – Sterile Injectables (Technology Transfer) USC Only

Hireproo LLC

Spokane (WA)

On-site

USD 85,000 - 120,000

Full time

13 hours ago
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Job summary

Hireproo LLC in Spokane, WA is seeking experienced Process Engineers to support technology transfer, manufacturing scale-up, and the launch of sterile injectable pharmaceutical products in a GMP environment.

The role requires hands-on experience moving processes from development or other facilities into commercial production, with strong expertise in process development, optimization, validation, and cross-functional collaboration.

Qualifications

  • Bachelor's degree in chemical/pharmaceutical engineering or related discipline.
  • 4–5 years of pharmaceutical manufacturing experience with sterile products.
  • Direct, hands-on experience supporting technology transfer for sterile injectables.
  • Strong understanding of process development, optimization, and scale-up.

Responsibilities

  • Support technology transfer activities for sterile injectable products.
  • Coordinate transfer of processes from development or existing facilities into commercial production.
  • Support process development, optimization, characterization, and scale-up.
  • Collaborate with Manufacturing, QA/QC, Validation, and Engineering teams.
  • Develop, review, and execute transfer protocols and process documentation.
  • Support process validation, including PPQ.
  • Ensure GMP/cGMP compliance and regulatory standards.
  • Identify opportunities to improve process efficiency and product quality.

Skills

Sterile injectable transfer
Technology transfer
Process development
Cross-functional collaboration

Education

Bachelor's degree in Chemical Engineering, Pharmaceutical Engineering, Biotechnology, Mechanical Engineering, or related discipline

Job description

We are seeking experienced Process Engineers to support the technology transfer, manufacturing scale-up, and launch of new sterile injectable pharmaceutical products within a GMP-regulated manufacturing environment.

The successful candidates will have hands-on experience supporting technology transfer activities for sterile injectable products, moving processes from development or existing manufacturing sites into commercial production.

This position requires strong technical expertise in pharmaceutical manufacturing, process development, process optimization, validation, and cross-functional collaboration.

Recent, hands-on sterile injectable technology transfer experience is mandatory.

Key Responsibilities
  • Support technology transfer activities for new sterile injectable pharmaceutical products.
  • Coordinate the transfer of manufacturing processes from development or existing manufacturing facilities into commercial production.
  • Support process development, optimization, characterization, and manufacturing scale-up activities.
  • Collaborate with Manufacturing, Quality Assurance, Quality Control, Validation, and Engineering teams.
  • Develop, review, and execute technology transfer protocols, technical reports, and process documentation.
  • Support process validation, including Process Performance Qualification (PPQ).
  • Ensure manufacturing processes comply with GMP/cGMP requirements and applicable regulatory standards.
  • Troubleshoot manufacturing process issues and implement corrective and preventive actions (CAPA).
  • Support new product introductions (NPI) and manufacturing readiness activities.
  • Identify opportunities to improve process efficiency, product quality, and manufacturing performance.
  • Ensure successful transition of sterile injectable products into routine commercial manufacturing.
Required Qualifications
  • Bachelor's degree in Chemical Engineering, Pharmaceutical Engineering, Biotechnology, Mechanical Engineering, or a related technical discipline.
  • Minimum 4-5 years of pharmaceutical manufacturing experience.
  • Direct, hands-on experience supporting technology transfer activities for sterile injectable products.
  • Strong understanding of pharmaceutical process development, optimization, and manufacturing scale-up.
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