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Job ID :
52051BR
Location :
US - California - Santa Clara
:
Job Description
When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. 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.

Director, Software Engineering

Essential Functions:
  • Lead all software engineering and product management functions for a distributed global team.
  • At the direction of the Finesse GM, and in partnership with the CTO and VP of R&D, participate in the creation and drive execution of our software product roadmaps. Develop architectural direction to support our product strategy.
  • Hire top talent and build cross-functional teams of software engineers, software quality assurance professionals and product managers. Manage to budget and do scenario planning as circumstances change.
  • Perform research in to industry trends, requirements, and approaches to help ensure strategy and roadmaps are successful in the market place.
  • Identify and define required system interfaces and map dependencies.
  • Educate Software teams about proper processes and approaches to take when developing solutions.
  • Participate in development and implementation projects in the role of program manager, project manager, or product owner as necessary.
  • Develop a network of experts throughout the organization, industry and suppliers. Bring company and industry knowledge as well as creative technical skills to product creation; be a content, sub-discipline specialist across the company.
  • Knowledge and understanding of the current industry guidelines for designing, manufacturing, testing and documenting biopharmaceutical process equipment. (ASME BPE, GAMP, cGMP, ISPE, etc.)
  • Ensure designs comply with current pharmaceutical standards applicable for the project such as ASME BPE, GAMP, cGMP, ISPE guidelines and our quality management system.
  • Monitor compliance to project scope, schedule and budget relative to the established baseline for projects. Ensure all technical documentation in accordance to the specification for the project.
  • Executes and coordinates all qualification activities included in the project (pre-Factory Acceptance Testing, Factory Acceptance Testing, and Site Acceptance Testing).
  • Ensure that software R&D can assist customers in their qualification and validation activities if requested.

Minimum Qualifications
  • BSc/MSc or equivalent in Computer Science, Computer Systems Engineering, Software Engineering or related discipline degree in Biochemical Engineering, Process engineering, Chemical engineering, Mechanical engineering, or equivalent is a significant advantage.
  • Minimum 10 years of experience of process engineering project management of equipment used in Biopharmaceutical manufacturing including large scale and complex projects involving the integration of multiple systems.
  • Direct leadership experience of software development and product management functions in a technical Biopharmaceutical environment.
  • Design experience with software used to control bioreactors, filtration, separation and capture equipment (direct or tangential flow, filtration, chromatography systems and columns etc.).
  • Experience \\working with outside vendors on integrated software modules.
  • Experience in qualification activities (FAT/SAT) for software in the biopharmaceutical industry.


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. Apply today http://jobs.thermofisher.com

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.

*IND-LSG


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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