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Job ID :
58777BR
Location :
US - Illinois - Mount Prospect
:
Job Description

Responsibilities:

  • Assist Engineering in authoring, executing, performing, and summarizing Qualification and Validation activities for new and existing equipment and processes including Impact Assessments, Validation Plans, User Requirement Specifications, Risk Assessment (FMEA), Commissioning, IQ, OQ, and PQ.
  • Work with Engineering to develop methods and procedures in accordance with applicable Quality/Regulatory requirements and industry best practices.
  • Author/revise SOPs related to Validation/Qualification, Operations, Engineering, and Facilities
  • Work with Maintenance/Facilities in developing and maintaining Calibration and Preventative Maintenance strategies.
  • Represent Engineering in cross-functional team meetings/projects, as required.
  • Effectively communicate with Leadership and all departments regarding Engineering activities.
  • Conduct root cause analysis, deviation resolution through corrective and preventative actions, client and internal observation resolution, and effectiveness checks for Validation, Engineering, and Facilities .
  • Plan, formulate, and manage all aspects of Engineering and Facilities projects including planning, vendor management, installation and qualification/validation.
  • Applies Good Manufacturing Principles in all areas of responsibility.
  • Play an integral role in Practical Process Improvement (PPI) program including development and integration of lean tools and methods.

Minimum Qualifications:

  • Currently pursuing a Bachelor’s degree in Engineering (or related major) from an accredited college
  • Minimum of 3.0 GPA.
  • Experience in a GMP environment is a plus.
  • Strong technical writing capabilities.
  • Must be able to effectively communicate with internal and external clients at all levels of the organization.
  • Must have the ability to work independently and/or in a team setting with little supervision.
  • Must have strong analytical skills.
  • Ability to multitask and plan/execute several projects simultaneously.
  • Ability to meet deadlines and work under pressure in a fast-paced environment.
  • This position works primarily in a Production environment. Must have the ability to occasionally lift up to 50 lbs. Some pushing, pulling, bending, and reaching may be required. Will be required to work in a refrigerated environment on occasion.



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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