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.
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.
- 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.
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