Validation Analyst/ System Analyst

Company Description

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.

Qualifications

Additional Information

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