Manufacturing Engineer III, Validations

Job Locations US-MA-Bedford
Posted Date 2 weeks ago(2/5/2018 8:36 AM)
Job ID
2018-1051
# of Openings
1
Category
Operations

Overview

The Manufacturing Engineer III shall provide technical leadership and accountability for validations within the organization including commissioning and qualification, and maintenance of the validated state, of all direct impact manufacturing systems used to support the clinical development and commercialization of multiple therapeutic drug substance platforms. The position is set in a dynamic, fast-paced start-up environment and shall require the individual to work on a broad range of tasks.

Responsibilities

•Lead and execute validation activities and validation assignments supporting all technical and manufacturing involving the qualification of new and existing facilities, utilities, equipment and/or computerized systems
•Write, execute, and lead facilities and equipment validations, reviewing and analyzing data, adhering to GMP regulations. Lead cross-functional teams to establish site validation master plans, cleaning validation master plans, etc for complex product development projects
•Incorporating continuous process improvements and policies including functional and user requirement specifications
•Specify and source process equipment, fixtures, packaging materials, and other equipment and materials to support manufacturing and product development for expansion and commercialization including high capital automation
•Technical lead for manufacturing for equipment or facility validations, participating in regulatory inspections
•Write and execute test protocols for trials of new materials, equipment, tooling, etc.

Qualifications

•Bachelor's Degree in Engineering, preferably Chemical
•Minimum of 5 years’ experience in validations in the  pharmaceutical industry 
•Ability to work with people at all levels
•Must be proficient with Microsoft Office, particularly Word and Excel
•Experience with SolidWorks or other CAD or solid modeling software preferred
•This position requires mobility and some physical ability to set up and work with equipment

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