Resilience in pharmaceutical manufacturing: what connected operations now require

Pharmaceutical manufacturing is becoming more connected and automated, with 95% of life sciences manufacturers using or evaluating smart manufacturing technologies.1 The focus is no longer whether to digitise, but how to coordinate systems and infrastructure without disrupting compliance or production stability. To meet rising demands for quality, efficiency and personalised medicine, facilities are adopting integrated production systems while preserving tightly controlled conditions. As processes grow more specialised and data-intensive, manufacturers are using interconnected systems to improve consistency, traceability and decision-making.

Manufacturers are under pressure to expand capacity, speed deployment and maintain consistent quality across sites. That strain is visible across the supply chain: the American Society of Health-System Pharmacists reported 223 active drug shortages in its latest national tracking, and the US Food and Drug Administration continues to cite manufacturing and quality issues, delays and discontinuations as common causes.2 As new therapies, personalised medicine and global supply chain demands increase the need for flexible production, manufacturers must become more agile without compromising regulatory rigour. In response, manufacturers are moving towards more integrated operating models built to improve visibility, resilience and coordination across production environments. This shift is changing more than the tools manufacturers use. It is changing how production, quality, facilities, IT and compliance teams work together across the enterprise. As more systems share data and more decisions depend on coordinated visibility across infrastructure and operations, resilience becomes a broader management challenge rather than a narrow question of equipment uptime.

As digital systems spread across production, manufacturers are moving from siloed oversight to connected operating models. Quality systems, manufacturing execution systems, building controls and infrastructure monitoring platforms now need to share data in real time. That can improve visibility and speed decisions, but it also raises the need for tighter governance and clearer coordination across systems. Historically, manufacturing systems operated separately, with limited links between facility infrastructure and enterprise software. That model is becoming harder to sustain as manufacturers seek clearer visibility across production, quality, maintenance and facility performance. PwC’s 2025 Digital Trends in Operations Survey found that 55% of operations and supply chain leaders already use artificial intelligence (AI) in some areas for scenario planning and operational transparency, while another 29% are testing or piloting it.3 But connections are not in themselves enough. Connecting data with a purpose and context is what is needed so that the data is valuable, timely and available at the point of decision-making.

In pharmaceutical manufacturing, this trend reflects a broader need to connect data across systems so teams can work from a shared operational view. Production, quality, maintenance, facilities and enterprise systems can no longer operate in siloes if manufacturers want timely insight into performance, compliance and site conditions. Standardised data practices and clearer visibility across these environments are becoming essential to day-to-day decision-making. That need extends across the enterprise and beyond it. Manufacturers increasingly must coordinate data and workflows across a range of internal teams, while also working with third-party vendors that support software, provide cloud platforms and monitor connected infrastructure. As these relationships deepen, interoperability, data governance and vendor management are becoming more important to keeping operations aligned.

These increasingly connected systems offer operational benefits, but they also multiply the dependencies manufacturers must manage. In biologics manufacturing, where environmental conditions and equipment stability must remain tightly controlled, even brief interruptions in supporting infrastructure can trigger added batch quality review, verification and remediation before production can resume. In some facilities manufacturing biologic therapies, even a ten-minute power interruption can compromise sensitive materials and force manufacturers to discard entire batches. In more severe cases, a half-hour outage can trigger recovery processes that take days or even a full week before production can safely resume. Recent infrastructure disruptions have shown how dependent pharmaceutical operations are on continuous system availability, especially for products that must stay within validated temperature ranges. During the April 2025 Iberian blackout, outages lasting more than eight hours disrupted power, digital systems, and telecommunications across Spain and Portugal. In Portugal, cold storage failures threatened temperature-sensitive medicines. The incident showed that for vaccines, biologics and other temperature-sensitive therapies, infrastructure resilience is closely tied to product quality, release confidence and supply continuity. As manufacturers scale more complex therapies, resilience planning must cover production systems, cold storage, facility infrastructure and the digital tools that monitor them.4

Manufacturers are also operating against a backdrop of growing instability across US electrical grids, where ageing infrastructure, extreme weather events and rising energy demand are increasing the frequency and operational impact of power disruptions. For pharmaceutical manufacturers, operational continuity depends on more than production equipment. Facilities rely on interconnected environmental controls, power, cybersecurity, access management, data platforms and building systems to maintain stable conditions. As these systems become more integrated, manufacturers need broader visibility, clearer coordination and stronger governance across infrastructure layers to support continuous operations and avoid disruptions.

Resilience is increasingly a business performance issue. A 2025 industry report found that UK and European pharmaceutical firms experienced the longest downtime disruption of any industrial sector, with incidents averaging more than eight hours and losses reaching up to £5m per hour.5 That kind of exposure is pushing manufacturers to look beyond traditional disaster recovery and assess how infrastructure failures, cyber incidents, workforce shortages and supplier interruptions could affect production output, capacity utilisation, batch release and margin. As a result, resilience planning now depends on tighter coordination between operational technology teams, cybersecurity leaders, facilities management and manufacturing operations. As pharmaceutical manufacturing becomes more connected, the value of integrated data depends on how well manufacturers manage the growing web of systems, teams and external partners around it. That makes operational resilience not just a matter of uptime, but of maintaining control, visibility and coordination across the broader production environment.

AI and autonomy are changing the workforce equation in pharmaceutical manufacturing, but they are not eliminating the need for human expertise. A 2025 Parexel survey found that 51% of biopharmaceutical leaders view AI experts as one of the top three roles they need to fill in the next three to five years, underscoring how quickly digital capability is becoming part of the industry’s talent strategy.6 At the same time, regulated production still depends on employees who understand process control, data integrity, quality systems and operational decision-making. Digital tools can help standardise workflows and surface better information, but in good manufacturing practice environments, experienced oversight remains essential because model outputs must be validated, changes must be controlled and accountability cannot simply be handed to an algorithm.

AI and advanced automation are becoming practical tools for data review, event categorisation, workflow management and operational analysis – but regulated manufacturing is not moving straight to autopilot. A 2025 National Association of Manufacturers survey found that 51% of manufacturers already use AI in their operations, with common applications including supply chain management, predictive maintenance, quality control and workforce support.7 In pharmaceutical manufacturing, that targeted adoption reflects the realities of regulated environments: AI can support batch production, process control and real-time quality monitoring, but outputs still need validation, governance and clear accountability assigned. Pharmaceutical companies are adopting AI in areas such as predictive maintenance, quality support and workflow analysis because those use cases can deliver value without shifting final decision-making away from validated processes and human knowledge. In practice, new tools should fit within existing quality systems, documented workflows and validation requirements before they can be used more broadly, which helps explain why successful adoption remains targeted.The adoption approach also depends on employees using these systems strategically. If training is weak or workflows are too complex, even capable tools can add friction instead of improving performance. In practice, automation works best when it reduces repetitive tasks and gives employees better information, while people continue to provide judgment, manage exceptions and maintain accountability for regulated decisions.

As manufacturing environments become more connected, performance will depend on how well companies align technology, governance and cross-functional execution. Managing data flows, system reliability and operational response is becoming a basic requirement for pharmaceutical production. Companies that define clear oversight and strengthen coordination across IT, engineering, compliance and operations will be better positioned to make faster decisions and maintain stable output. Operational resilience now extends beyond equipment uptime or the protection of individual systems. It includes the ability to coordinate infrastructure, cybersecurity, workforce decisions and production oversight across connected environments. That makes resilience as much an organisational issue as a technical one, shaped by governance, workforce readiness and day-to-day coordination.

That shift also pushes resilience beyond the plant floor. As production systems become more interconnected, manufacturers need stronger coordination across internal teams, facility infrastructure and third-party technology providers. In practice, data governance, vendor alignment and operational visibility are becoming core parts of resilience strategy rather than adjacent concerns. The challenge now is to improve efficiency without weakening security, compliance or continuity. Connected operations can give manufacturers better visibility and control, but they also raise the standard for how risk is managed across production and digital infrastructure. Those that take a more integrated approach to operations, oversight and resilience planning will be better prepared for the next phase of pharmaceutical manufacturing.

Owen Bonner is chief operating officer for Honeywell Life Sciences, where he helps lead solutions for digital transformation, manufacturing and quality management in regulated life sciences environments. He has more than 15 years of experience in the life sciences industry, including leadership roles across automation, consulting and engineering. Before joining Honeywell, Bonner served as director of Sales and Operations for Werum IT Solutions in Ireland and the UK. He has also represented Honeywell in industry forums on Pharma 4.0, digital manufacturing and integrated life sciences operations.

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Resilience in pharmaceutical manufacturing: what connected operations now require