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Hello ,

Hope you are doing well,

I do have requirement for the below position, let me know if you are interested

Process Validation Engineer || St. Louis, MO, (Hybrid)  || C2C

USC, GC, GC-EAD, H4 || Duration : 12 Months || End-Client : Takeda

Working with Prime Vendor || Experience : 7 +

Job Description:

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

Regards,

Jitendra Chauhan

IT Recruiter

jitendra@techcentertechnologies.com

Techcenter Technologies Incorporated

3240 East State Street Ext, Hamilton, New Jersey 08619