Automation Lead

We are supporting a highly automated biopharmaceutical manufacturing organisation looking for an experienced Automation Lead to take technical ownership of automation across upstream production . The role will support the full automation lifecycle, from system design and project delivery through commissioning, qualification, production start‑up and ongoing GMP operations.

Responsibilities

• Provide technical leadership for automation across upstream manufacturing and drug substance operations .
• Act as a key SME for DeltaV DCS, batch control and OT systems .
• Support automation design, configuration, testing, commissioning, qualification and operational handover.
• Work with automation supporting bioreactors, media preparation, and single-use systems
• Lead or support FAT, SAT, IQ, OQ and PQ activities.
• Ensure automation systems comply with GMP, validation, data integrity, alarm management and regulatory requirements .
• Partner with Manufacturing, Engineering, Quality, Validation, IT/OT, Process Development, vendors and system integrators.
• Support change control, deviations, CAPAs, lifecycle management and continuous improvement .
• Improve process control, batch execution, recipe management, data traceability and manufacturing reliability.
• Support integration between process automation, historians, MES and wider manufacturing systems.

Requirements

• Strong automation experience within pharma, biotech, biologics, CDMO or another GMP-regulated manufacturing environment .
• Proven experience supporting upstream processing or drug substance manufacturing .
• Strong hands‑on expertise with Emerson DeltaV .
• Good understanding of automated bioprocessing, batch systems and GMP process control.
• Practical exposure to fed-batch processes, bioreactors, single-use bioreactors, media preparation and upstream support systems .
• Experience across commissioning, qualification, validation, troubleshooting and automation lifecycle activities.
• Strong understanding of GMP documentation, change control, data integrity, deviations and CAPAs .
• Ability to lead technical discussions and work across multidisciplinary teams.
• Fluent English required; German would be advantageous.

Advantageous Experience

• Biologics, biosimilar or CDMO manufacturing
• Single-use bioreactor and mixer systems
• Process historians such as AVEVA PI
• MES / manufacturing system integration
• Environmental monitoring or laboratory system interfaces
• Greenfield or brownfield biotech projects

#DeltaV #Upstream #USP #Bioreactors #Single-Use #DrugSubstance #GMPAutomation #Batch Control #FAT/SAT #IQ/OQ/PQ #DataIntegrity #MES #PIHistorian #OTSystems #Biologics