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About No deviation
At No deviation , we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.
We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.
Position Overview
We are seeking an experienced IT/OT Project Lead to lead the assessment, planning, and implementation readiness for a site-wide upgrade of OT computerized systems to Windows 11 LTSC. The environment includes approximately 70+ GMP and non-GMP OT system assets distributed across Manufacturing, QC Laboratories, and Development Laboratories. The role will initially focus on conducting a comprehensive current-state assessment and developing a detailed, phased project roadmap covering technical feasibility, system dependencies, resource requirements, cost estimates, timelines, risks, procurement requirements, and implementation strategy. The successful candidate should have sufficient technical understanding of OT infrastructure, computerized systems, and regulated manufacturing environments to effectively engage with Engineering, Manufacturing, QC, IT/OT, Quality, vendors, and system integrators.
Key Responsibilities
Lead a comprehensive assessment of the current OT computerized system landscape, including Windows OS versions, hardware, applications, interfaces, and dependencies.
Develop an inventory and categorisation of approximately 70+ GMP and non-GMP OT systems across Manufacturing, QC, and Development Labs.
Assess system readiness and compatibility for migration to Windows 11 LTSC.
Engage equipment vendors, application vendors, and system integrators to confirm Windows 11 compatibility, hardware requirements, software/application upgrade requirements, licensing requirements, and vendor support requirements.
Define a risk-based and phased upgrade strategy for the site.
Develop the overall project plan, including scope, WBS, schedule and milestones, cost estimates, resource requirements, procurement requirements, vendor support, and risk management.
Develop business case and budgetary estimates for project approval.
Define implementation sequencing to minimise impact to manufacturing and laboratory operations.
Develop the proposed approach for testing, commissioning, system verification/qualification, cutover, rollback, and operational handover.
Coordinate stakeholders across Engineering, Manufacturing Operations, QC, Development Labs, IT/OT, Quality, and vendors.
Establish project governance, risk tracking, and management reporting.
Support vendor selection, technical evaluation, and tender/RFP activities where required.
Prepare the project for transition from assessment and planning into execution.
Required Qualifications
Degree in Engineering, Information Technology, Automation, Computer Science, or a related discipline.
Strong project management experience involving OT systems, industrial IT infrastructure, or computerized systems.
Good understanding of Windows operating systems, OT infrastructure, industrial computerized systems, network and system dependencies, and cybersecurity considerations.
Experience within pharmaceutical, biotechnology, or other regulated manufacturing environments strongly preferred.
Ability to work across both technical and business stakeholders.
Experience coordinating equipment vendors, software vendors, and system integrators.
Familiarity with project planning tools such as Microsoft Project, Primavera, or equivalent.
Why join us?
Generous Leave Policy.
Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.
How to apply
Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!
Please submit your resume, outlining your qualifications and experience relevant to the role, here.
