Investigator, MS&T Specialist - 2404961
๐ Join Our Team! Investigator, MS&T (14357768) ๐
๐ Location: Princeton, NJ
โฐ Shift: Mon-Fri, 8 AM to 5 PM
๐ Duration: Minimum 3 months, with potential to hire for the right candidate
๐ฅ Positions Available: 2
Note: This position is only open to U.S. citizens.
๐ฌ Role Overview:
The MS&T Specialist provides technical support to the Princeton, NJ Facility for manufacturing processes in a GMP environment. Responsibilities include troubleshooting process and equipment-related issues, collaborating with Manufacturing and Quality teams, conducting root cause analyses, implementing preventive actions, and participating in process tech transfers and improvements.
๐ Key Responsibilities:
๐ง Functions as a technology and process subject matter expert.
๐ฉโ๐ฌ Provides on-the-floor and on-site technical support to manufacturing when necessary.
๐ Authors, reviews, and approves various documents (e.g., Batch records, SOPs).
๐ Authors and approves protocols and reports in accordance with regulatory expectations (APS, Engineering, Tech Transfer).
๐ Analyzes and summarizes manufacturing data to support impact assessments and investigations.
๐ Owns change controls for process and procedure changes.
๐ Leads and executes CAPA system investigations.
๐ Leads technology transfer efforts for new processes and product implementation.
๐ Performs tech transfer facility fitness, gap analysis, and risk assessment when onboarding new programs.
๐ง Applies continuous improvement tools to identify and close procedural and compliance gaps.
๐ก Identifies opportunities for process improvements and operational efficiencies, leading implementation efforts.
๐ Represents MSAT and interfaces with other functions such as Process Development, Supply Chain, Quality, Validation, and Facilities & Engineering.
๐ง Supports equipment and systems validation activities, including reviewing qualification documents, drafting user requirement specifications, and participating in impact assessments.
๐งฅ Ability to perform gowning activities and enter the manufacturing plant.
โ๏ธ Some travel will be required.
๐ Education and Experience Requirements:
๐ BSc and/or Advanced degree in Science or Chem/Bio Engineering.
๐งช Minimum 5 years of industry experience.
๐งฌ Minimum 3 years of relevant experience in GMP biologic/cell therapy manufacturing technical or process support.
๐ Advanced degrees preferred.
๐ง Knowledge and Skills Requirements:
๐ฌ Scientific understanding of bioprocessing principles, familiarity with cell therapy processes, and cGMP strongly preferred.
๐ง Experience in process qualification, validation.
๐ญ Experience with the startup, validation, and licensure of new biopharmaceutical manufacturing facilities is a huge plus.
๐ ๏ธ Experience with program management software and tools are a plus.
๐ Experience working with external parties and/or cross-functional teams.
๐ Experience interfacing with clients.
๐ฃ๏ธ Possess strong verbal/written communication skills and ability to influence at all levels.
๐ Ability to think strategically and translate strategy into actions.
โฑ๏ธ Ability to prioritize tasks in a highly dynamic environment.
๐ง How to Apply:
Send your updated resume to: careers@proqualitynet.com
Include the job title in the subject line.
Don't miss this exciting opportunity to be a part of something extraordinary! Apply now and share this post to help us find the perfect candidates. ๐
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