Work in a critical role within a software development team at an international bioanalytical contract research organization.
Gather, analyse, validate, document, and manage requirements for an active Labware laboratory information management system (LIMS) with an incrementally widening scope.Needs GxP experienceResponsibilitiesFirst point of contact for business stakeholders requiring fixes, changes and additions to the product, working closely with developers to achieve quick turnaround on priority issues.Manage the existing pipeline of underway and upcoming requirements.Evaluate incoming requests against intended system function, project scope, and product governance priorities.Elicit and analyse high quality requirements from stakeholders ensuring all requirements and technical specifications are well documented throughout their life-cycle.Write and maintain supporting project and validation documentation to facilitate development and implementation of solutions in a GxP regulated environment.Manage the existing requirements catalogue, and supporting documentation, ensuring good communication and visibility with all stakeholders.Work with developers and testers to ensure the product can meet technical specifications and user requirement specifications.Engage with business stakeholders in several countries and support global governance of the product.Facilitate communications between scientists, developers, customers, and all other stakeholders.Present the product and new functionalities to internal and external stakeholders.Skills, Education & QualificationsSolid proven experience in all aspects of business analysis and requirements engineering.Experience of validation and deployment of systems in a highly regulated scientific environment.Experience working with a software development team to manage project workflow and ability to share a leadership role in such a team.Proven ability to act as a product owner, presenting to clients, working with leadership teams, and being an advocate for the product.Working knowledge of LIMS systems and their main use cases in a bioanalysis workflow.Experience analysing complicated scientific and technical concepts, and excellent oral/written communication skills to present these to non-scientific and non-technical stakeholders.Ability to attend UK Cambridgeshire site on a semi-regular basis when the need arises.Willingness to travel globally and work occasionally outside of normal business hours.Strong analytical skills and excellent attention to detail.Proven ability to manage a challenging personal workload using personal initiative to prioritise and adapt.Good IT skills and experience of using various software packages.