Business Analyst

Business Analyst

Address the work will be performed:

Hybrid Philadelphia

PA Target start date: 4/3

Length of contract assignment: 8 months

Work schedule/typical work week/daily start and end time: • 40 hours,

Mon-Fri • 8am to 5pm

Onsite at the Philadelphia location 3 days/week

Visa: All

Rate: $75/hr C2C

Client description: • Medium sized Biotechnology company that focuses on Cell & Gene Therapies • Provides R&D and Manufacturing services. • IT Organization is going through some changes and will now be aligned through Facilities leadership. • Multiple high priority IT projects in 2023 in preparation for onboarding of new client, Johnson and Johnson.

Project description: • Client is looking for a senior BA with GxP regulated Lab Applications/Systems experience. • Manage MES workstream for Implementation of a new platform • Will be responsible for analyzing lab apps (Discover, Documentation, Workflow) and developing the lifecycle management plans. • Project champion for migration of Blue Mountain RAM CMMS to the cloud • Engage with stakeholders on the environmental monitoring project to perform gap analysis of environmental monitoring software. • Support regulatory and compliance team on the migration of document management system from local version 1 to enterprise version 5. • Work with stakeholders and manage the examination of current lab systems and applications and determine if they are a fit for intended purposes. • Organize workflows and ownership of all systems currently in place. • Provide recommendations/guidance on which systems/applications are non-core.

Consultant's day to day responsibilities: • Participate in GxP validation activities (writing and reviewing protocols) • Discovery activities including interviewing stakeholders, SME's, vendors/suppliers. • Developing SOP's, training documentation, test plans and test cases. • Act as additional resource for current BA team supporting priority projects. • Lead work sessions, focus groups and vendor workshops to capture clear user requirements. • Work with business stakeholders to define expected outcomes and establish KPI's.

Required Skills: • Prior Experience as Business Analyst in the Pharma IT space, must have:

o Experience in GxP, 21 CFR Part 11 environment

o Served as the lead BA on a full life cycle implementation project.

o Served as BA on an MES project

Desired Skills • EBR, ELN project experience preferred. • Served as a BA on Building and Manufacturing Applications (Ex: Rees Scientific, ELPRO and Empower CDS.)