Labware Engineer

Sr. Labware Professional to work all aspects of the role.

Business Analyst

• Work as a member of the LIMS Development team to evaluate business processes, elicit requirements from Subject Matter Experts (SME), and write comprehensive project documentation to facilitate development and implementation of solutions.
• Evaluate and document existing business processes with appropriate techniques e.g. shadowing, gap-analysis, SOP review, flow analysis, etc.
• Elicit requirements from SMEs flexibly while adhering to the project scope, from one-to-one conversations during shadowing of work through to large global workshops.
• Ensuring that SMEs feel engaged and empowered to act within a project, making sure that all voices are heard and valued throughout the process.
• Writing user requirement specifications (URS) from the information gathered during elicitation. Ensuring that the URS is organised and worded in a manner that is easily understood by all stakeholders regardless of specific technical knowledge.
• Lead URS reviews with all relevant stakeholders to ensure that the requirements of a project are accurately understood and agreed by all.
• Translating signed off requirements into Technical Specification documentation from which developers can design and build the required solution.
• Lead Technical Specification requirement reviews where developers and the business can discuss and approve granular system design to ensure prosed solutions will be fit for purpose.
• Continually reviewing and maintain the business requirements and technical documentation as projects progress, ensuring all stakeholders and project team members are made promptly aware of process, requirement, or development changes.
• Assisting the software development team with all aspects of their work; explaining processes, reviewing complex test-cases, and acting as the go between with them and the business as required.
• Assisting with system validation, supporting the Computer System Validation team flexibly, especially in helping them to risk assess when required.
• Acts as point of contact between different divisions within Resolian (locally and globally), breaking down complex technical processes into understandable concepts and to facilitate communication of ideas between individuals with different technical skills.

Project Manager

• Acting as the primary point of contact for internal and external stakeholders regarding the system and its projects.
• Provide system presentations and demonstrations to clients as required, supporting the commercial team in communicating the current system, and planned future development.
• Writing and maintaining project plans, project timelines, and supporting project documentation.
• Communicating project timelines and events to the project stakeholders.
• Leading global governance calls to assess and prioritise system development.
• Plan and implement LIMS projects across the global Resolian footprint.
• Assist the project governance team in defining project scope, goals and deliverables, and creating documentation to support these decisions.
• Define tasks and required resources required to implement projects.
• Manage the resourcing of LIMS team personnel across the projects, and ensuring their work is directed as priorities dictate.
• Liaising with operational staff to ensure adequate resource is provisioned for system testing and necessary workshop/project support.
• Manage the project budget, both for internal and external resourcing costs.
• Manage the systems budget, including new and ongoing license support costs, and acting as the primary contact for the system vendor.
• Create project schedule and timelines, ensuring these are accurate and communicated routinely to relevant stakeholders.
• Support and direct the LIMS development team.
• Present to stakeholders reports on progress as well as problems and solutions
• Implement and manage changes when necessary to meet project deliverables
• Evaluate and assess the result of the project, ensuring continuous improvement is implemented.
• Generate and deliver monthly system KPIs as required by the business.

System Trainer/Champion

• Act as the lead trainer during the go-live of a newly developed solution, both through live training, and the generation of training videos/documentation.
• Provide hyper-care during the go-live of a newly developed solution, being flexibly available to answer questions, provide support, and assist the developers in closing any defects found during launch.
• Once a solution progresses into normal usage after an initial go-live period, training appropriate super-users to take over training responsibilities and act as the first line of support for issues.
• Assisting with user acceptance testing, ensuring users feel engaged and that real life scenarios are put through the system to ensure that the solution is fit for purpose.
• Advocate for the system within the business to ensure that best practices are followed, and compliance with training is maintained.
• Setup appropriate training and monitoring systems, ensuring that adequate controls are in place to prevent unauthorised access to the system is prevented.
• Translating user questions/bugs/issues into requirements for developers to resolve.
• Raising incidents and quality documentation to allow for developers to implement fixes to the system as required.
• Assisting with system administration tasks such as account access, permissions, and system report generation.
• Assist development testers in generating test data and strategies to test complex pathways.
• Assist the validation team in generating test data and strategies to validate complex pathways.
• Assist users and developers in generating non-standard reports as required by client requirements at short notice.

Behaviours

Acts as a member of different global teams to deliver diverse projects, reporting to the global LIMS governance board.

Planning and coordinating their time across multiple projects to achieve milestones while maintaining strong communication of progress and potential delays.

Maintains accurate documentation throughout the lifecycle of a project and distributes this to stakeholders as required.

Proactively investigates potential targets for automation and process improvement within the company.

Manages and empowers software, user, and validation testers flexibly as required, ensuring they have the knowledge and context they require to accurately test the system.

Able to rapidly pivot between competing workflows, prioritising constantly evolving tasks to ensure project momentum is maintained.

Able to distil complex technical concepts into easy to understand explanations to ensure non-technical staff can understand the programme of work.

Able to translate scientific concepts and business processes into technical terminology that can be understood by system developers to create an appropriate system design.

Able to manage a diverse governance team with competing priorities.

Able to help and support users of varying skill levels to understand the system.

Key Responsibilities and Accountabilities

• Acts as a member of the Development team; helping to analyse the needs of the business, capture requirements, highlight areas of improvement, and develop and implement solutions.
• Acts as a project manager; able to work alone in steering and delivering complex projects within timelines and under budget.
• Acts as a system champion/trainer; supporting users with complex queries, and training staff on new functionality.
• Acts as the central point of contact between developers, operational staff, project governance, testers and wider stakeholders for all project related information.
• Ensuring project documentation is wrote and maintained to a high standard.
• Training staff on deployed implementations and maintaining training resources.
• Investigates processes which are suitable for automation and facilitates the deployment of relevant
• A confident communicator, able to present to internal stakeholders, clients, and regulatory investigators.
• Complies with relevant SOPs in all work undertaken.

Knowledge, Experience and Technical Skills

Essential

Experience of working within a CRO utilising a LIMS system.

Strong understanding of the business requirements of a CRO, intricate knowledge of systems and workflows required for success.

Experience of analytical work, preferably including use of LIMS.

Experience in the validation and deployment of automated systems.

Strong analytical and problem solving skills.

Ability to work in an organised and methodical manner.

Positive ‘can do’ attitude.

Able to lead workshops comprising an array business departments.

Ability to work as part of a team or independently as required.

• Relies on experience and judgment to plan and accomplish goals.
• Self-motivated with the ability to prioritize, meet deadlines, and manage changing priorities.
• Proven ability to be flexible and work hard, both independently and in a team environment, in a high pressure environment with changing priorities.
• Willingness to work occasionally outside of normal business hours.

Good IT skills and experience of using various software packages.

Customer and quality focussed.

• Excellent oral and written communication skills with proven ability to simplify complex technical information for a business customer and business/science information for a technical customer.
• Able to rapidly develop a good understanding of a large range of disparate scientific disciplines and procedures.
• Willingness to travel globally.