This IT project will deploy a standard environmental monitoring solution worldwide. Project phases include initiation, validation, deployment prep and eventual deployment to at least 9 manufacturing sites.
Responsibilities:
- Work with the project manager to drive the project, including all SDLC processes.
- Work with the vendor and the project team to become a subject matter expert in MODA.
- Provide application support for the MODA system.
- Collaborate with subject matter experts, microbiologists, and Informatics colleagues to understand and generate cohesive documentation of business processes, identify business challenges, and gather & analyze current practices and standards.
- Develop and maintain a business rules & data dictionary of elements within scope of the solution space.
- Identify instances where existing processes may be streamlined or improved.
- Deliver documentation to the vendor for development and implementation. Facilitate vendor’s work by clarifying requirements, as needed.
- Work with the existing support team to deploy and test the vendor’s solutions in the environment.
- Collaborate with subject matter experts and analytical & bioanalytical scientists to develop and execute user acceptance tests for all deliverables.
- Play a key role in providing training for and deploying all deliverables.
- Work with the existing IT operations team to support deliverables post-release.
Skills and Experience Required
- At least 7 years of prior experience working in an analyst capacity on large and/or complex projects in the Biopharmaceutical/Pharmaceutical Industry.
- Familiarity with Pharmaceutical Development IT.
- Experience with Computer Systems Validation, working knowledge of 21 CFR Part 11.
- Experience with LIMS systems.
- Experience with MODA is a plus.
- Familiarity in understanding microbiology processes in general is a plus.
- Experience in an analyst capacity on a large scale COTS project, a custom development project, and/or combination of both (impacting 100+ Users across multiple domains).
- Experience with formal SDLC practices, emphasis on Analysis & Design stages.
- Demonstration of autonomous analysis planning and management.
- Ability to elucidate requirements from a diverse group of scientists and operational support business representatives that span multiple sites and departments, during workshops, interviews, and pilot settings.
- Proven ability in gathering, tracing, translating and managing complex requirements, business rules, and data.
- Adept at simplifying extremely complex processes and procedures.
- Excellent oral and written communication skills; organizes and presents ideas in a convincing and compelling manner.
- Exceptional technical writing / documentation skills, specifically of key analysis deliverables (business/functional/technical requirements, use cases, process mapping).
- Exceptional interpersonal skills; able to communicate effectively with both technical and non-technical teams; able to provide technical leadership.
- Outgoing personality; self-starter able to work interactively and independently as part of a cross site team with minimal supervision, and manage and prioritize work across multiple work streams of a large program.
- Possess strong business acumen; possess a broad, enterprise-wide view and understanding of strategy, processes and capabilities, enabling technologies, and governance.
- Knowledge and experience with Lonza’s MODA and related systems are a plus
- Bachelors or Master’s Degree in computer science, engineering, physical sciences, life sciences, or logistics
- Experience with process modeling tools (ARIS, Visio, etc.) to identify, capture, define, and analyze business processes
- Strong proficiency in MS Excel, Word, PowerPoint, Outlook, SharePoint
Position Requirements
• Travel between New Brunswick and manufacturing sites may be required during the deployment phase of this project.