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Manufacturing Engineer II

  • Bedford, MA
  • Direct Hire
  • Job ID: OR21-2710031

$80000 to $85000 Per Year

Manufacturing Engineer II-Bedford MA

 no relocation package available for this role

The Manufacturing Engineer II,  supports Chromatography Resin manufacturing operation as a key technical resource and subject matter expert of production, production processes, and its supporting system. They will partner with the team to manage change, perform technical reviews of identified problems, and support new product introductions from the Pilot Plant into Large Scale Manufacturing. They will encounter recurring work situations of high complexity, with frequent variations from the norm.

Responsibilities:

  • Performs frequent Engineering Change Orders within the Agile change management tool consisting of Validations, IQOQ’s, batch record updates, etc.
  • Assists Engineering Sciences team with startup / commissioning a state-of-the-art chemical manufacturing facility
  • Develops Flex Team members, Shift Leaders, and Manufacturing Sciences Engineers as a technical leader
  • Supports the deviation process within Trackwise (Initial Assessment, Investigation, Root Cause Analysis, and CAPAs) as a Process Owner
  • Investigates and Implements Capital Expenditure projects (Capex) as requested to support the POROS Value Stream
  • Manages the execution of special projects as assigned by Operations management

Qualifications:

  • Minimum required education: Bachelor degree in Chemical Engineering (or similar engineering discipline) with 3 years manufacturing support experience
  • Knowledge of cGMP and safety (OSHA) regulations desirable
  • Familiarity working in a Class I Div I Hazardous Location Manufacturing Environment
  • Batch chemical manufacturing processes
  • Experience with the following systems: Delta V (Process Control System), Agile (Change Order Management), Trackwise (Problem Reporting and Root Cause Counter Measure software),
  • Ability to Excel in a fast pace, demanding environment undergoing double digit annual growth
  • Ability to work semi-autonomously and provide indirect leadership to other technical resources while executing the goals of the organization.

In this role you will be a part of the Bioproduction Group, based in the Bedford, MA facility where we manufacture POROS Chromatography resins, used by our pharmaceutical customers near the end of their process to purify their treatments, therapies, vaccines, etc.

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