Engineering
Engineering Innovation in Life Sciences
Designing and delivering robust industrial systems is essential in Life Sciences, where performance, compliance, and reliability must be ensured from the outset. ALTEN supports organisations across the full engineering lifecycle, from concept design and facility engineering to equipment integration and commissioning.
Our approach adapts to each project’s complexity and regulatory constraints, ensuring that infrastructure, utilities, and processes are designed to meet both operational and compliance requirements. By combining technical expertise with industry knowledge, we help deliver efficient, scalable, and future-ready environments that support the entire product lifecycle.
What is Process Engineering ?
Introducing a process from R&D into commercial manufacturing is a critical transition point. You need to preserve process intent while meeting industrial, safety, and productivity constraints. We support your process engineering, scale-up, and industrialisation efforts through URS definition, risk analysis (dFMEA/eFMEA), FAT and SAT management, commissioning, manufacturing support, and mechanical design optimisation. This ensures your manufacturing systems are ready to perform under real production conditions.
Case study
In the complex lifecycle of pharmaceutical manufacturing, moving from pilot processes to full-scale production requires precision, technical depth, and rigorous compliance. ALTEN provides strategic support to one of its main clients’ Engineering & Maintenance department, ensuring that process engineering activities are not only functional but optimised for efficiency, reliability, and regulatory compliance at scale.
While leading in the global pharmaceutical market, this client faces the ongoing challenge of maintaining high-performance production lines while navigating evolving process requirements. Read about how we are supporting them.
What is CQV?
Ensuring that equipment, systems, and processes operate as intended is a critical step in Life Sciences environments. You need to guarantee compliance, performance, and data integrity while meeting stringent regulatory requirements. ALTEN supports your Commissioning, Qualification and Validation (CQV) activities across the full lifecycle, from commissioning and qualification to validation, combining risk-based approaches, regulatory expertise, and digital tools. This ensures your systems are compliant, reliable, and ready for consistent production.
Case study
In the highly regulated Life Sciences landscape, ensuring that facilities and equipment are properly commissioned, qualified, and validated is essential to secure product quality and compliance. ALTEN supports one of its key clients in structuring and executing CQV activities, ensuring alignment with both operational objectives and regulatory expectations.
Operating in a context of evolving regulations and complex production environments, this client must accelerate project timelines while maintaining a high level of quality and compliance. Read about how we are supporting them.
What is Tech Transfer?
Transferring a process across sites, scales, or technologies is a critical step in Life Sciences, where maintaining product quality, performance, and compliance is essential. You need to ensure continuity between source and target environments while managing technical, operational, and regulatory constraints. ALTEN supports your technology transfer projects from initial assessment to deployment, combining risk analysis, structured methodologies, and regulatory expertise. This ensures a smooth transition without compromising performance or compliance.
Case study
In the complex context of pharmaceutical manufacturing, technology transfer projects require strong coordination, detailed process understanding, and strict regulatory alignment. ALTEN supports one of its key clients in preparing and executing transfer activities, ensuring continuity between production sites and consistency of product quality.
Operating in a highly regulated and time-sensitive environment, this client must manage process changes, documentation updates, and risk mitigation while maintaining operational performance. Read about how we are supporting them.
What is Project Management?
Project management in Life Sciences plays a critical role in ensuring that complex technical activities are executed efficiently, within strict timelines, and in full compliance with regulatory standards. From coordinating engineering and validation activities to managing internal and external stakeholders, effective project management helps control risks, handle deviations, and maintain alignment with GMP and client procedures. By structuring planning, monitoring progress, and adapting to unexpected issues, project management ensures that critical operations are delivered on time while maintaining quality and compliance.
Case study
In the demanding context of pharmaceutical operations, managing large-scale CAPEX projects requires structured methodologies and strong cross-functional coordination. ALTEN provided project management support to a client to plan, monitor, and adjust all shutdown-related activities, including engineering tasks, testing, and supplier coordination, while managing discrepancies through root cause investigations.
This structured approach ensured controlled execution of activities, adherence to timelines with limited delays, and 100% closure of discrepancies within deadlines, supporting compliant and efficient project delivery.
What is CSV?
As your digital landscape expands, traditional Computer System Validation (CSV) approaches built on exhaustive documentation and rigid testing can slow transformation efforts. Cloud platforms, automation, and agile development demand validation strategies that focus effort where risk truly lies. Computer Software Assurance (CSA) shifts validation toward what matters most (patient safety, product quality, and system impact) using critical thinking, automated testing, and scalable practices. ALTEN supports your transition from CSV to CSA, reducing validation effort while maintaining full compliance with 21 CFR Part 11 and GAMP 5, so you can adopt new technologies without weakening regulatory control.
Case study
In the high-stakes world of global vaccine distribution, the ability to confirm regulatory compliance for batch release in real-time is a massive competitive advantage. ALTEN provided specialised CSV (Computerised System Validation) leadership to support the deployment of iRelease SBRS, an ERP-agnostic dashboard. We ensured that this digital engine, which powers critical batch release decisions, meets the most stringent global data integrity and GxP standards. Deploying a core-model digital solution across international is a complex regulatory and technical undertaking. Read more about our involvement below!
What is Supply Chain ?
Supply chain management in Life Sciences is critical to ensuring the continuous and reliable delivery of products across global markets. It involves coordinating demand forecasting, production planning, inventory management, and distribution while maintaining strict compliance and service levels. In a highly regulated and demand-driven environment, companies must balance stock availability, cost efficiency, and responsiveness to market changes. ALTEN supports supply chain teams in optimising planning processes, improving forecast accuracy, and enhancing collaboration across internal teams and external partners, ensuring efficient and resilient end-to-end operations.
Case study
In the complex environment of pharmaceutical supply chains, ensuring product availability while maintaining cost efficiency requires strong coordination across global operations. ALTEN supports a leading healthcare company, in optimising its end-to-end supply chain planning processes for key products such as Rivotril and Valium.
Operating in a demand-driven and highly interconnected network, the client must continuously align forecasts, production, and inventory across multiple international sites, while managing supplier collaboration and stock risks. ALTEN contributes to this effort by supporting demand and supply planning activities, coordinating API orders, and improving visibility across the supply chain to secure service levels and operational performance.
Our case studies
our PARTNERS
Interested by our expertise within Engineering?