Project Leader (IT) – Computer systems validation

April 20, 2021 IT / Internet

Job Overview

Job title: Project Leader (IT) – Computer systems validation

Company: Zany Consulting Group

Job description: Project Leader (IT) – Computer Systems Validation

Zany Consulting Group

Build a better career with Zany Consulting Group

Serving customers and community starts with the most talented people doing their very best work. That is precisely what we have at Zany Consulting Group, a leading Professional Services Consulting firm. Zany Consulting Group is seeking exceptionally driven, experienced Project Leader (IT) to undertake projects for one of our clients in Toronto, Ontario.

In this role:

The primary purpose of this position is to function within the Information Solutions Department as a leader of the design, development, testing, documentation, validation, and support of approved IS business projects that will facilitate the development and management of systems within the Industrial Operations (IO) business process area with respect to information capture, storage, analysis and reporting.

A person in this position may lead projects that are local, regional or global in scope, and that have an extensive impact on the business. Examples of the types of systems that the individual will work with include data acquisition systems, document management systems, web applications, Laboratory Information Management Systems, manufacturing automation systems, SAP, etc.

The Information Technology and Solutions (ITS) department supports the major business areas within our client firm with dedicated teams. The ITS Industrial team is seeking external support for two projects required by Industrial Affairs in Toronto: * Electronic logbooks Pilot: implementation and validation of off-the-shelf software for digitizing paper forms and logbooks used with the manufacturing process. This project is a pilot for our client and requires defining the deployment process for other sites, and evaluation of software to confirm expected benefits at the conclusion of the pilot.

NuGenesis SDMS 8 Rollout: migration of laboratory instruments from legacy NuGenesis 7 to our client global instance of NuGenesis 8 for archival of instrument data

Responsibilities:

The majority of the position’s responsibilities are related to system implementation tasks such as:

Business case development; Resource management (including proactive assignment of resources to IS projects); Leadership of project implementation teams; Development of project plans and day to day management of IS projects; Process design, business data, process, and workflow modeling; Software selection; Interaction with Sr. Business Analysts and Business Analysts who may manage day to day tasks at a more detailed level; Managing IS and other project team resources across multiple projects to get projects completed; Change management; Management of project budgets via capital and deferred software funds; Establishment and maintenance of a common framework to support application development, including project management standards, software configuration control, change management, user support and training, testing procedures, validation, and quality assurance; Coordinated reporting and presentation of project status, resource allocation, and other project-related information to IS management.

Prepare Project Plans. Execute projects according to approved Project Plans. Coordinate and track business and ITS activities required to deliver the project.
Maintain project schedules following ITS Project Management Methodology (PUMA) to ensure projects are delivered on time and on budget per defined scope. Manage issues impacting project schedules as they arise and proactively propose solutions. Identify, track and manage project risks.
Monitor and control the project progress and provide visibility on status. Organize, prepare and report to the Project Steering Committee.
Facilitate project meetings, including providing agendas, meeting minutes, and ensuring that meetings are effective. Utilize Microsoft Teams for project team collaboration.
Coordinate with external vendors, ITS quality, global quality, site quality, and internal ITS infrastructure teams as needed to meet the project deliverables.
Work closely with business project leads and ITS team to document requirements, define business processes, and determine configuration settings. Participate in the development of electronic logbooks as needed.
Coordinate with Validation Expert (VEX), User Project Lead (UPL), and ITS Project Lead (IPL) to produce, review, and obtain approval for technical and validation documentation such as User Requirements Specifications, Functional Specification, Design Specifications, Protocols, Test Scripts, and Installation Procedures as required by the project. Ability to assist in documentation creation as required.
Support knowledge transfer on electronic logbook development to internal staff.
Ensure support model is identified for delivered solutions and coordinate transition to support organizations as required.
Understand the computer validation process & the PUMA methodology for executing projects.

Skills and Qualifications:

5+ years experience as a Project Manager in software / IT systems deployment
BA/BS Sciences, Engineering, Information Systems, or Business Studies
Strong technical documentation, communication, and reporting skills
Strong skills with database structures
Software administration experience
SDLC experience
Thorough knowledge of all desktop personal productivity software (i.e. Office, Project, Visio)

Preferred:

Computer Systems Validation experience
Prior experience in GxP FDA-regulated environment
Ability to manage relationships with external vendors

Zany Consulting Group strives to help our customers achieve greater productivity, profitability, and quality work through a team of experienced consultants in the pharmaceutical industry. When you join our team, you will receive rewards and recognition for your contributions, training and professional development opportunities. If you are inspired to learn, take risks, and succeed as a team, you can build a better career at Zany Consulting Group.

Equal Opportunity Statement: All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity.

Job Type: Contract