Jobs · Engineering · Massachusetts

Bioprocess Engineer

Stark Pharma Solutions Inc · Framingham, MA · 4 mo ago
On-siteEngineeringContract

Position Overview

We are seeking motivated Bioprocess Engineers to support biopharmaceutical manufacturing operations, process engineering initiatives, and technology transfer activities within a GMP-regulated environment.

Key Responsibilities

  • Support upstream and downstream bioprocess manufacturing operations in a GMP environment.
  • Assist with process monitoring, data analysis, process trending, and performance evaluations.
  • Participate in technology transfer, process characterization, and process validation activities.
  • Support manufacturing investigations, deviations, CAPAs, and change control initiatives.
  • Collaborate with Manufacturing, Quality, Process Development, Validation, and Engineering teams.
  • Generate and maintain technical documentation, reports, and process records.
  • Analyze process data and identify opportunities for process improvements and operational efficiencies.
  • Support manufacturing readiness, troubleshooting, and continuous improvement initiatives.

Required Qualifications

  • Bachelor's degree in Chemical Engineering, Bioengineering, Biotechnology, Biochemistry, Life Sciences, or a related field with 2-4 years of relevant industry experience;
  • OR Master's degree with 1-2 years of experience in biopharmaceutical manufacturing, process engineering, or process development.
  • Experience supporting biopharmaceutical or biologics manufacturing operations.
  • Familiarity with upstream and/or downstream unit operations, including:
    • Cell Culture
    • Chromatography
    • Filtration
  • Strong proficiency in Microsoft Excel and data analysis.
  • Excellent organizational, documentation, and communication skills.
  • Ability to manage multiple priorities in a fast-paced GMP environment.

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