Job title: Director Software Engineering
Location: Enderby, Leicestershire UK
- 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.
- 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.
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