Technology Operational Readiness Lead - Drug Product Manufacturing
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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.
