Lead, Process Validation Job in Boston, Massachusetts US

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COMPANY INFO:         

My Client is a global leader in the design and manufacture of injection molded plastic products  They are a trusted source in their industry, and have customers in many industries who rely on their expertise in technical services and products.  Their Boston area facility has identified the need for a LEAD, PROCESS VALIDATION to direct validation process development and execution.  What a great opportunity for a  quality professional!!!

 

The LEAD, PROCESS  VALIDATION  will:

·           Plan and draft validation documents Validation Change Owners (Quality, Engineering, IT, Manufacturing and assure proper execution/documentation of test results

·           Review and approve validation documents and ensure that validation documentation is compliant with applicable policies, procedures and requirements

·           Contribute to the development and refinement of validation processes

·           Ensure that validation packages contain all relevant information to support any changes proposed.

·           Write Validation Master Plans, remediation plans, and Process Validation Summary reports

·           Review and provide feedback to plant and corporate policy writers on new and revised validation guidelines, specifications and policies.

 

The  LEAD, PROCESS VALIDATION will have:

·           BS degree in Engineering or  Life Science

·           5+ years working in a GMP environment, with 4+  years of direct validation experience   

·           Thorough knowledge and understanding  cGMPs, FDA and pharmaceutical industry guidelines

·           Knowledge of Quality Systems (QSR 21 CFR 210, 211,  Part 11 and 820),

·           Working knowledge of statistics

·           Effective interpersonal and problem solving skills .  

·           ASQ Certified Quality Engineer

·           Boston area residency preferred

 

Qualified candidates please submit salary info and your resume as an MS Word attachment to jkroehler@mri-boston.com

 

Key words are: BS  Engineering or Life Science,  validation, Pharmaceuticals, cGMP, QSR  21 CFR 210, 211, Device, Quality Systems,, ASQ Certified Quality Engineer, statistics