Technology Operational Readiness Lead - Drug Product Manufacturing

Overview

The Technology Operational Readiness Lead is accountable for ensuring that the extensive portfolio of digital, automation, IT, and operational technology systems delivered by project teams are production-ready, supportable, compliant, and value-realising at go-live and throughout the operational lifecycle.

This role bridges the gap between project delivery and steady-state operations, ensuring that technology investments made to enable a state-of-the-art drug product manufacturing facility translate into sustained business outcomes, operational excellence, and long-term maintainability.

The role acts as the single point of accountability for technology readiness, coordinating across Engineering, Automation, IT, Quality, Manufacturing, Digital, Cybersecurity, and external partners.

Responsibilities

1. Technology Operational Readiness Strategy

• Define and own the Technology Operational Readiness (TOR) strategy for a major manufacturing transformation programme.
• Establish clear readiness criteria across people, process, technology, data, security, compliance, and support.
• Ensure readiness is embedded into project plans from design through PPQ and handover, not treated as a late-stage activity.

1. Deployment Readiness & Go-Live Assurance

Lead readiness assessments for all major systems including (but not limited to):

• Automation & PCS/SCADA platforms
• MES, Historian, Data Platforms (EDL/CDL)
• Digital, AI, IIoT, analytics, and visualization tools
• Infrastructure, cybersecurity, access control, identity, and monitoring solutions

Ensure each system meets defined go-live exit criteria, including:

• Validated/qualified state
• Operational procedures and SOPs in place
• Support and escalation models established
• Monitoring, alerting, and backup strategies live

Act as the final readiness sign-off authority prior to operational handover.

1. Operability, Support & Sustainment

Define and implement post-deployment operating models for all technologies:

• Support ownership (L1/L2/L3)
• Vendor vs internal responsibilities
• ServiceNow / ticketing integration
• Patch, upgrade, and lifecycle management

Ensure systems are maintainable by site teams, not dependent on project SMEs or vendors.

Drive alignment with global and site support organizations.

1. Business Value Realisation

Ensure technology deployments are explicitly tied to business outcomes, such as:

• Throughput, OEE, quality, compliance, reliability
• Reduced manual effort and error
• Faster decision-making through data and analytics

Define KPIs and success measures to confirm value is realised post go-live.

Partner with Manufacturing, Quality, Engineering, and Digital teams to course-correct where value is not being achieved.

1. Change, Adoption & Capability Enablement

Lead the human and organisational change aspects of technology introduction.

Ensure operators, engineers, quality, and support teams are:

• Properly trained
• Confident using new systems
• Clear on new ways of working

Ensure adoption is measured and actively managed, not assumed.

1. Governance, Risk & Compliance

Identify and mitigate operational risks related to technology introduction.

Ensure alignment with:

• GMP and regulatory expectations
• Cybersecurity and data integrity standards
• Global IT/OT and digital architecture principles

Act as a key contributor to design reviews, risk assessments, and governance forums.

1. Cross-Functional Leadership

Act as the integrating leader across:

• Project teams
• Site operations
• Global digital and IT functions
• Quality and validation

Influence without direct authority, driving alignment and decisions across complex stakeholder groups.

Key Interfaces

• Manufacturing & Operations Leadership
• Engineering & Automation
• IT / Digital / Data / Cybersecurity
• Quality & Validation
• Project & Program Management
• Global Technology & Digital Teams
• External System Integrators and Vendors

Qualifications

Essential

• Senior experience (10+ years) in manufacturing technology, automation, digital, or IT/OT within regulated environments (pharmaceutical, biotechnology, or medical device industries).
• Proven leadership in technology deployment at scale, from design through steady-state operations.
• Deep understanding of operational readiness, system handover, and lifecycle management.
• Strong working knowledge of GMP, validation, data integrity, and regulated operations.
• Experience operating across PCS/SCADA, MES, infrastructure, and enterprise digital platforms.
• Excellent stakeholder management and executive communication skills.

Desirable

• Experience in greenfield or major brownfield manufacturing programmes.
• Exposure to advanced digital manufacturing concepts (AI, analytics, IIoT, digital twins).
• Experience defining or operating site or global technology support models.
• Background in manufacturing operations, engineering, or technical leadership roles.

Leadership Profile

• Systems thinker with strong business orientation.
• Pragmatic, outcomes-focused, and comfortable with ambiguity.
• Able to challenge design and delivery decisions constructively.
• Trusted partner to both project teams and site operations.
• Comfortable operating at both strategic and hands-on levels.