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Job ID :
55524BR
Location :
US - California - Fremont
:
Job Description

As the world’s leader in serving science, Thermo Fisher Scientific is a driving force in the research, healthcare, industrial and applied markets, generating more than $18B in annual revenue. No other company can match our range of customer touch points – technologically, geographically or commercially. We help our customers in finding cures for cancer, protecting the environment, making sure our food is safe and moving forward with thousands of important projects that improve millions of lives.

Specialty Diagnostics Group:

The Specialty Diagnostics Group (SDG) serves customers in healthcare, clinical, pharmaceutical, industrial, and food safety laboratories. SDG consists of a dedicated team of 6,900 talents determined to improve diagnostic methods in order to improve patient care and accuracy of diagnoses. The group offers a wide range of diagnostic test kits, reagents, culture media, instruments and associated products. Together, we are moving medicine forward by bringing advanced diagnostic tools that improve the quality, reliability and speed of diagnostics

Clinical Diagnostics Division:

The Clinical Diagnostics Division (CDD) aims to be the leading provider of high value, innovative diagnostics solutions to select IVD market segments and a partner of choice for major OEM customers. More than 1,900 sales professionals represent an extraordinary variety of product lines: : Diagnostic Reagents for drug abuse screening, therapeutic and immunosuppressant monitoring, serum toxicology, endocrine, specimen validity testing, and sepsis testing; Clinical chemistry and Molecular controls; Particle Technology; and Corporate accounts.


Job Description:

  • Support Operations management requirements to achieve target levels of customer service.
  • Develop, implement, and maintain manufacturing processes and the related documentation required to manufacture every product within its specifications, schedule, and budget.
  • Assess equipment status and identify risk of obsolescence, upgrade needs or potential productivity gains. Evaluate and implement necessary upgrades to maintain a world-class manufacturing environment.
  • Identify work related hazards and assist with the implementation of safer alternatives.
  • Assist the Facilities Department on complex mechanical failures and determination of appropriate preventive maintenance activities.
  • Participate in production daily meeting to resolve current equipment and process issues.
  • Support the validation of new and modified manufacturing equipment, processes and materials.
  • Provide hands-on sustaining engineering efforts to develop and improve manufacturing process.
  • Provide engineering support to improve product manufacturing first pass yield and quality concerns.
  • Seek PPI Project opportunities for improvements in key measurement areas (speed, cost, quality, and productivity). Drive high dollar product quality projects that produce significant value for the business through sustaining engineering activities.
  • Work in concert with the Manufacturing and Facilities departments to identify, correct, and prevent equipment reliability issues.
  • Work with the Manufacturing and Quality departments to develop and train on standard operating procedures and work instructions.
  • Maintain and ensure systems and procedures are compliant with regulatory requirements and Thermo Fisher Scientific policies and procedures.
Minimum Requirements:
  • Bachelor Degree in an engineering science.
  • 5 years of experience in the cGMP regulated industry.
  • 5 years of experience Sustaining Engineering, Manufacturing Engineering or Quality Engineering.
  • Experience with SolidWorks and AutoCAD.
Preferred Requirements:
  • Mechanical engineering preferred.
  • Mechanical understanding of equipment typically used in the biotech industry.
  • In-vitro diagnostic experience preferred.
  • Demonstrated experience with Lean Manufacturing principles.
  • Ability to perform failure investigation.
  • Understanding of QSR and ISO 13485 requirements.
  • Good analytical skills and ability to communicate effectively with all levels.

At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.




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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