Our client is implementing a new LIMS application globally replacing multiple existing electronic systems and paper processes with one harmonized global application. The project is in the testing / qualification phase for the first pilot release, and in the initial planning phases for subsequent functionality expansion of the platform.
The scope of this role is to work closely with the R&D and plant labs to understand their needs and determine how they will be met with a standard software LIMS package. The role will build an excellent understanding of the project guiding principles, operating mechanisms, and functionality road map to ensure a high quality delivery. The role will ensure compliance to the validated solution requirements, ensuring responsible activities are conducted within these guidelines, including self-created deliverable s.
Define and develop standard work roll out deliverable s to be used across all locations, which help the sites understand and migrate their existing system and process to the new global LIMS platform.
Accountable for demonstrating solid technical analysis skills, strong business knowledge, require limited direction, handle complex problems, possesses extensive knowledge of laboratory processes, including rolling out new processes and systems, and strong written and oral communication and interpersonal skills.
As this is a project will have global stakeholders, some project meetings will occur during non-standard US business hours.
This individual will need to:
• Determine key implementation requirements, and work with other project team members to define implementation options, key risks, assumptions, effort, and benefits (ROI). Most standardization efforts will be common across many locations, with a few differences based on a global geographic region.
• Gain a strong understanding of the project guidelines and principles. Gain a strong understanding of the LIMS application functionality and the implications for implementation decisions and the overall implementation road map. This role will have a primary focus on Environmental Monitoring and Stability function areas.
• Create the appropriate validated implementation deliverable s, including User Requirements documents.
• Work closely with project resources and management teams to deliver on time and budget.
• Work and guide a lab to map its current process, investigating details and asking questions where a deeper understanding is required. Work with site labs on a GAP analysis identifying mitigation’s for each gaps. Subsequently, implement the new solution at laboratory sites.
• Define and articulate business rules required for data accuracy and consistency.
• Identify, analyze, propose and document appropriate solutions for problems and issues. Identify and understand issues that may impact day-to-day operations and or project costs. Use technical tools for (queries, process maps, etc.) for problem resolution.
• Effectively determine when to escalate open questions, issues, and risks to the Project Manager.
• Strong writing and communication skills, including the ability to tailor the same content to multiple audiences.
• Solicit continuous improvement input and enhance existing standard work templates
• Bring creative solutions to solve business problems, looking beyond the obvious or typical approaches.
• Possess team collaboration skills; effectively work with multiple cultures and working styles.
• Effectively work in a large project structure with multiple peer work stream business analysts.
• Understand and follow appropriate system life cycle development process, quality validation processes and application processes.
– Communicate status, solutions and concerns. Disseminate information in a timely manner within the team and across functions or teams. Establish and maintain relationships within the business or function.
• International travel is not expected, however may occur, therefore a valid International Passport holder is required.
• Bachelor’s degree, with 5+ years experience in applying information systems solutions to business problems. Experience in requirements definition, system testing, validation, problem resolution, and training.
• Implementation in the Pharma, medical device industry is highly desired, but not required.
• Ability and flexibly extend into subsequent project phases: As this is a multi-year project there is expected to be opportunities for this role to extend beyond the contract end date
For Immediate Placement - Andrew Raynor Dover New Hampshire