Validation Analyst/ System Analyst

Integrated Resources Inc.; New Brunswick (NJ); On-site; USD 100,000 - 125,000; Full time

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.