Validation Analyst/ System Analyst

Job Description

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.

Additional Information

All your information will be kept confidential according to EEO guidelines.