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
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Automation Lead in Berlin Arbeitgeber: Discover International
Als Arbeitgeber in der biopharmazeutischen Fertigung bieten wir Ihnen die Möglichkeit, in einem dynamischen Umfeld zu arbeiten, das auf Innovation und Qualität ausgerichtet ist. Unsere Unternehmenskultur fördert Teamarbeit und kontinuierliches Lernen, während wir Ihnen durch gezielte Schulungen und Entwicklungsmöglichkeiten helfen, Ihre Karriere voranzutreiben. Darüber hinaus profitieren Sie von einem modernen Arbeitsplatz, der mit den neuesten Technologien ausgestattet ist, und einer flexiblen Arbeitsumgebung, die Ihre Work-Life-Balance unterstützt.
