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Job ID :
43098BR
Location :
US - New Hampshire - Portsmouth
:
Job Description

When you join us at Thermo Fisher Scientific, you’ll be 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.


Position Summary:

A senior-level engineer to lead projects in the development of new manufacturing processes to deliver innovative glass products for the Anatomical Pathology Division. The individual will design, develop, scale-up and optimize robust operations that provide high product quality at various scales ranging from Concept to full scale manufacture. Strong collaboration is expected with internal and external R&D groups, internal commercial partners, and external third party OEMs. The candidate should have strong communication & interpersonal skills, be able to multi-task and have a commitment to continuous learning.


Responsibilities:

  • The key duties of this role are to be the technical leader on wet chemistry and chemical coatings of glass substrates. The role will be responsible commercial start-up efforts as well as providing support for investigations and identifying process optimization and harmonization opportunities within global manufacturing operations.
  • This role is expected to have a strong lab/pilot plant presence: design and execute statistical studies with a focus on process understanding & robustness, interpret and present data, participate in cross-functional development teams, and author technical reports.
  • Provide technical leadership for start-up of new manufacturing process lines.
  • Utilize theoretical and practical expertise to troubleshoot and resolve technical issues with experimental studies or commercial operations.
  • Identify and implement process improvements into on-going operations with emphasis on yield improvement and reducing process variability.
  • Generate documentation to support process design and implementation activities within a ISO 13485 environment.
  • Support approval inspections by serving as technical expert for development and processing operations. Present, where appropriate, technical data to internal or external audit groups and commercial partners.
  • Build strong relationships with internal and external stakeholders and take advantage of these relationships to identify new opportunities.
  • Ensure all company and departmental policies and procedures are adhered to



Minimum Education and Experience Requirements

  • BS in Chemical/Mechanical Engineering or related Science and 5+ years of experience. Significant experience in development through GMP manufacture, and scale-up/optimization of high volume consumable products is required.
  • Minimum of 5 years of experience in process development, process engineering or related commercial scale-up/manufacturing in the medical device industry
  • Experience in leading/executing product development programs for early phase development through commercial validation/launch
  • Experience in technology transfer of process to manufacturing facilities
  • Demonstrated technical expertise for developing new and existing technology based processes, ensuring a high level of technological competency
  • Experience in a Process Development environment and a fundamental understanding of Quality by Design methodology in developing GMP processes
  • Demonstrated to develop innovative solutions to unique problems, simultaneously works on multiple highly complex projects with a detailed understanding of how multiple systems interact.


Technical Knowledge/Skills Needed:

  • Demonstrated track record in generating technical options to resolve problems, prioritizing options to test, selecting optimal solutions based on available data, and implementing decisions
  • Strong technical skills focused on fundamental understanding and optimization of manufacturing process operations such as CVD, Wet chemistry coatings, drying, etc.
  • Experience using theoretical modeling to aid in fundamental understanding of heat and mass transfer and drying.
  • A basic understanding of regulatory agency requirements, including but not limited to FDA, MHRA, EPA and OSHA.
  • The ability to interact well with diverse groups, including R&D, Engineering, Validation, and Manufacturing; maintain collaborative working relationships with internal and external partners.
  • Strong written and verbal skills to effectively communicate complex technical information to audiences of varied levels of experience and technical expertise.
  • Demonstrated self-directed work habits and time management skills.
  • Computer skills: word processing, data processing, DOE, graphing and presentation, project management.



At Thermo Fisher Scientific, each one of our 50,000 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.

*IND-SDG




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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