Thermo Fisher Scientific Job - 31454988 | CareerArc
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Company: Thermo Fisher Scientific
Location: Bedford, MA
Career Level: Associate
Industries: Healthcare, Pharmaceutical, Biotech


Here at Thermo Fisher Scientific, you are a part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $17 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

The Manufacturing Engineer, POROS is responsible for supporting the POROS manufacturing operation as a key technical resource and subject matter expert of production, production processes, and its supporting system. He/She 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. He/She will encounter recurring work situations of high complexity, with occasional variations from the norm.

Nature and Scope:

Works on assignments that are complex in nature where judgment is required in resolving problems and making routine recommendations. Normally receives no instruction on routine work and minimal instruction on new assignments.


  • Supports a culture of Safety and Quality focus with the team
  • Identifies and implements continuous improvement ideas to increase productivity by supporting the Project Funnel Process / PPI (Practical Process Improvement) efforts
  • Improves the production processes by utilizing the tools outlined in PPI and supports POROS team members in their improvement efforts
  • Writes / revises Standard Operation Procedures (SOPs) and Bill of Materials (BOMs)
  • Explores opportunities with India Engineering team for SOP updating synergies
  • Performs Initial Engineering Change Request for MFG within the Agile change management tool
  • Supports the deviation process within Trackwise (Initial Assessment, Investigation, Root Cause Analysis, and CAPAs) as a Process Owner
    • Develops Flex Team members, Shift Leaders, and Manufacturing Sciences Engineers with PR investigations as needed
  • Partners with shift leadership to address and report on barriers in daily manufacturing with countermeasure proposals
  • Develops and mentors Flex team members (both those assigned to POROS Large Scale as well as the Flex pool) as a Subject Matter Expert (SME) for POROS manufacturing processes
  • Responsible for the monthly Product Quality Reviews process (creation, execution of the meeting, and followup on action items)
  • Develops, Investigates, and Implements Capital Expenditure projects (Capex) as requested to support the POROS Value Stream
  • Assists in the training of personnel as needed (new hire support, tech transfer support, personnel growth with existing team members)
  • Leads / Assists POROS Redundant Manufacturing Project, including (but not limited to), facility review, facility design, manufacturing process flows, system reviews, supporting Capex projects, IQOQPQ, initial startup, etc.
  • Owns Technology Transfers / Scale Up projects from POROS Pilot Plant to Large Scale POROS including headcount recommendations, timing of transfer, becomes SME of new product manufacturing process, provides training on new processes, etc
  • Investigates Electronic Batch Record feasibility and potential implementation
  • Coach others on procedures, team work, and leads by example while exemplifying positive behavior
  • Creates and owns personal Development Plan
  • Operations Direct Support (less than <15% of total time)
    • Provides Line Clearances for Production Processes as needed
    • Completes Batch record reviews and trains high potential team members on the batch record review process
    • Contributes to Direct Labor as requested to support operations (less than <15% of total time)
  • Manage the execution of special projects as assigned by Operations management
  • Demonstrates Thermo Fisher Scientific values – Integrity, Intensity, Innovation, and Involvement
  • Performs other duties as assigned

Minimum Qualifications:

  • Bachelor's degree in a scientific or technical field as well as knowledge of plant operations (manufacturing, distribution, maintenance)
  • 5 Years of Manufacturing Experience
  • Working knowledge of SAP
  • Working knowledge of Delta V
  • Working knowledge of Agile (or similar Engineering Change Request / Order (ECR/ECO) system)
  • Working knowledge of Trackwise (or similar deviation management system)
  • Ability to handle complex processes independently as well as with a team as required
  • Ability to work non-standard hours as required
  • Ability to support weekend operations as required
  • Ability to travel as needed (<5%)
  • Excellent oral and written communications skills required
  • Ability to exert up to 50 lbs of force occasionally to lift material as well as push full 55 gallon drums on wheeled dollies
  • Ability to stand for 80% of the shift
  • Ability to move ~40 lbs up one flight of stairs
  • Ability to wear all Personal Protective Equipment (PPE), including work uniform, steel toe shoes, hair net, safety glasses, bump cap, and latex gloves. PPE may also include face shield, respirator, and smock

Preferred Qualifications:

  • Bachelor's degree in Biology, Chemistry or Engineering preferred
  • Knowledge of cGMP and safety (OSHA) regulations desirable

This position has not been approved for Relocation Assistance

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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