Director of Software Engineering
- Recruiter
- Thermo Fisher Scientific
- Location
- Loughborough
- Salary
- Competitive
- Posted
- 09 Oct 2017
- Closes
- 01 Nov 2017
- Sectors
- Engineering
- Contract Type
- Permanent
- Hours
- Full Time
Job Description:
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.
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.