Engineering - Assistant/Associate Scientist
Listed on 2026-10-09
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Engineering
Regulatory Compliance Specialist
Assistant/Associate Scientist
Onsite required for Training
Hybrid 50/50 once training is successfully completed
Work Schedule:
Mon - Fri, Business Hours
* Some weekends required based on the needs of the Business
* • Provides technical expertise for large-scale commercial manufacturing involving column chromatography, microfiltration, ultrafiltration, nano-filtration, and cryogenics / drug substance handling unit operations for investigation and resolution of process deviations, development, and interpretation of data trending.
• Develops, drafts and executes protocols per corporate, site and regulatory requirements to support qualification and validation activities.
• On-the
-floor support for process related issues
• Performs data collection and analysis for process monitoring
• Demonstrates a strong knowledge of cGMP compliance, Client corporate, site and regulatory agency requirements and procedures and incorporate into all assigned projects.
• Supports process technology transfer, process validation and the preparation of CMC documentation for regulatory filings for Client Devens Large Scale Cell Culture & Single Use facility.
• Authors technical documents, including protocols, reports and SOPs supporting the validation of the biopharmaceutical product manufacturing.
• Knowledge or experience in upstream & downstream unit operations and technical writing (validation and regulatory document authoring) attained through prior experience or studies resulting in a B.S. in biology, chemistry, and/or engineering, a related discipline, or its equivalent.
Education and Experience:
• MS or BS in Chemical/Biochemical Engineering or related field with 4-7 years, respectively, or relevant industrial and/or academic experience
Additional
Job Requirements:
Position Handles Hazardous Materials
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