Hello,
I have mentioned all the details below.
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Job Title
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Process Validation Engineer
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Location
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St. Louis, MO (Hybrid,)
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Tax Terms
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C2C
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Conversion Salary
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N/A
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Work Authorization
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USC, GC, GC-EAD, H4
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Duration
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12 Months
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End-Client
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Takeda
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Tier
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Working with Prime Vendor
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Experience
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7-20 Years
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Job Description
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BIOLOGICS EXPERIENCE AND CMO OVERSIGHT IS A MUST HAVE!!!!!!
RESPONSIBILITIES:
• Provide technical support and routine process monitoring for commercial products manufactured at CMOs.
• Provides person-in-plant observations of manufacturing operations at CMOs and communicates observations to the product team.
• Reviews manufacturing processes, deviations, and/or development and production data.
• Reviews manufacturing batch records, protocols, and control strategies.
• Provide technical support and data analysis for investigations and deviation resolution.
• Recommends changes or additional experiments to improve quality, productivity, recovery, and overall efficiency.
• Interacts with colleagues and external partners from various functions, such as Engineering, Manufacturing, and Quality departments
• Oversees and reports on overall manufacturing progress.
BASIC QUALIFICATIONS
• Bachelor’s degree in engineering or science with 8 years of experience
OR
• Master’s degree in engineering or science with 5 years of experience
• Experience in biologics development, bioprocess engineering, technology transfer, and / or commercial manufacturing operations
PREFERRED QUALIFICATIONS
• Experience with Good Manufacturing Practices and supporting a commercial facility
• Experience in cell culture and/or downstream purification (direct lab experience a plus)
• Experience with equipment qualification and process validation
• Familiarity with formal root cause analysis and/or risk assessment
• Experience working with statistical analysis software and investigative data analysis
• Experience with project leadership
• Experience communicating with cross functional teams
• Strong technical writing and communication skills
• Proficient in Microsoft Word, Excel, and PowerPoint
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Thank You
Regards
Shreya Dwivedi
Technical Recruiter
VSG Business Solutions
[email protected]
3240 East State Street Ext, Suite 203, Hamilton, NJ 08619