Site IT Project Requirements & Technical Readiness Consultant

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.

Due to a constant growth, PQE Group is looking for a Site IT Project Requirements & Technical Readiness Consultant to support our projects in Swindon

Our client requires an experienced Site IT Project Requirements & Technical Readiness Consultant to support a portfolio of Manufacturing, Engineering, Laboratory and IT projects.

The purpose of this engagement is to improve the quality and consistency of IT engagement within Site Projects by ensuring technical requirements are identified, documented and coordinated early within the project lifecycle.

The Consultant will provide specialist technical knowledge to facilitate project discovery, requirements capture, technical coordination and operational readiness, enabling projects to progress efficiently through technical review and into implementation.

This engagement is intended to deliver a defined programme of project work and is not intended to provide operational IT support or replace an existing operational role.

Responsibilities include, but are not limited to

• Design and implement a standard Site IT Demand Intake Process, including stage gates, checklists, templates, governance checkpoints and project initiation guidance, and coordinate its adoption across site projects.
• Review project scope, objectives and existing documentation to establish the technical baseline for each project and determine the appropriate level of IT engagement.
• Gather and document business, technical and operational requirements, including review of vendor documentation and equipment specifications.
• Identify and document infrastructure and integration requirements, covering networking, hosting, storage, application dependencies, integrations, backup/recovery, disaster recovery and operational support needs.
• Capture governance and compliance-related requirements, including application ownership, Role-Based Access Control (RBAC), Segregation of Duties (SoD), Configuration Items (CIs), validation and compliance considerations.
• Identify and document technical risks, assumptions and dependencies, providing inputs to the project risk register.
• Prepare Technical Review Board (TRB) submissions and supporting governance documentation, and coordinate inputs for Architecture Reviews, Corporate Cybersecurity reviews and Infrastructure/Validation engagement.
• Track technical actions arising from governance reviews and maintain project technical documentation throughout the project lifecycle.
• Coordinate operational readiness activities, including identification and creation of Configuration Items with operational teams, and gathering information for Incident Management, Backup & Recovery, Disaster Recovery and Scheduled Maintenance procedures.
• Coordinate preparation of operational support and handover documentation, including the Integration Register, application support models, scheduled jobs and automation details.
• Coordinate project transition activities, confirming that required technical information has been captured and governance reviews completed, and facilitating technical handover to the Site IT Infrastructure Team.
• Support project readiness reviews and ensure technical information is complete, consistent and available to delivery teams for technical evaluation, solution design and implementation.

Required Qualifications

• Minimum 6 years of experience in IT project coordination, technical requirements capture and readiness within regulated manufacturing environments.
• Regulated manufacturing and life sciences expertise, including GxP/GMP environments, Computer Systems Validation (CSV), and experience in pharmaceutical or life sciences manufacturing (desirable).
• Technical domain knowledge across Manufacturing IT and Operational Technology (OT), Laboratory Systems and instrument integration, IT Infrastructure, Industrial Networking and Cybersecurity principles.
• Requirements capture and documentation — proven ability to identify, gather and document business, technical and operational requirements, and to produce clear, consistent technical documentation.
• Technical coordination and stakeholder engagement — ability to coordinate between Project Teams, Vendors, Site IT and Global IT, with strong cross-functional communication skills.
• Governance support — ability to prepare and coordinate governance review inputs (TRB, Architecture, Cybersecurity) without owning technical approval, and to track technical actions, dependencies and risks across multiple projects.
• Operational readiness knowledge — understanding of Configuration Items, Incident Management, Backup & Recovery, Disaster Recovery and Scheduled Maintenance requirements, and ability to coordinate operational support and handover documentation.
• Adaptability and vendor management — ability to work across projects at different maturity levels, adapt engagement accordingly, and manage vendor documentation and specifications effectively.

Next Steps

Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview. If there's a positive match, a technical interview with the Hiring Manager will be arranged. In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal. Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.

Working at PQE Group

As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world. If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you. Apply now and take the first step towards an amazing future with us.