Bioprocess Engineer
Stark Pharma Solutions Inc · Framingham, MA · 1 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.