Director, Automation Engineering & CSV

Our Work MattersAt Kindeva we make products that save lives ensuring better health and well-being for patients around the world. Why KindevaPurpose-driven work environmentSignificant growth potentialCollaborative team cultureDirect impact on patient careIndustry-leading innovationAt Kindeva we make products that save lives ensuring better health and well-being for patients around the Impact You Will Make:Lead the Future of Pharmaceutical Automation. Join a growing pharmaceutical CDMO where your leadership will establish and standardize automation strategy across three manufacturing sites with varying automation maturity. You will serve as the enterprise automation leader responsible for new facility stand-up all supporting and filling equipment automated visual inspection systems auto-injector and device assembly automation packaging integration serialization and full lifecycle system ownership from specification through will combine deep pharmaceutical automation expertise with strong organizational leadership to build a scalable sustainable automation program that supports operational excellence regulatory compliance and long-term talent development. This is a highly visible leadership role with significant impact across multiple sites and :Enterprise Automation StrategyStandardize controls architecture PLC/HMI platforms data systems and automation a robust lifecycle management program aligned with GAMP and regulatory modernization initiatives for legacy systems while ensuring minimal operational Facility & Capital Project LeadershipLead automation strategy for major expansion development and oversight of URS FS DS FAT/SAT commissioning qualification and PPQ seamless integration from equipment procurement through validated commercial technical oversight during capital justification and vendor selection -Finish & Inspection AutomationProvide subject matter expertise in:Automated visual inspection (AVI) for syringes and vialsCosmetic and particulate detection technologiesReject management and data capture systems Ensure inspection systems meet global regulatory and data integrity -Injector & Combination Product AutomationLead automation oversight for auto-injector and specialty device assembly systems including:Automated visual inspection (AVI) for syringes and vialsNeedle safety system integrationPlunger rod insertion and final device assemblyFunctional device testing (force timing deployment verification)Traceability and tamper-evident integrationEnsure compliance with combination product regulatory Serialization & Specialty PackagingOversee packaging automation platforms including:Multi-carton configurationsBlister packagingSpecialty packaging for combination productsAuto-injector final pack-out systemsSerialization and aggregation (unit through pallet).Ensure compliance with DSCSA EU FMD and global track-and-trace requirementsIntegrate packaging and serialization systems with enterprise data & Commercialization OwnershipProvide automation leadership from concept through with Validation and Quality to ensure compliant IQ/OQ/PQ automation reliability performance monitoring and OEE structured change control and digital lifecycle documentation -Site Technical OversightHarmonize automation standards across three standardized spare parts strategies and obsolescence escalation leadership for critical automation modernization roadmaps based on risk and operational Development & Talent StrategyBuild and lead a high-performing automation engineering structured onboarding and certification pathways for new cross-training frameworks to ensure operational a formal succession planning and competency development a sustainable staffing model balancing capital project demand and operational & Data IntegrityEnsure compliance with:21 CFR Part 11Annex 11GAMP 5 lifecycle standardsCombination product regulatory audit readiness across automation systems and digital with IT/OT to strengthen cybersecurity and system :RequiredBachelors degree in Engineering or related technical field required; Masters degree preferred.10 years of progressive pharmaceutical automation success leading automation for new fill-finish or device manufacturing experience in validation commissioning and commercialization leadership experience in building and developing automation expertise in: Automated visual inspection (vials and syringes)Auto-injector assembly and device automationFormulation filling inspection and packaging automation and serialization systemsMulti-site automation leadershipCore CompetenciesPharmaceutical fill-finish automationCombination product and device assembly automationPackaging & serialization integrationPLC SCADA HMI MES architectureLifecycle validation and data integrityMulti-site standardizationOrganizational development & succession planningStrategic capital executionPhysical RequirementsEmployees are required to follow all cGMP and safety wear all required PPE and perform assigned work in a safe use proper lifting techniques and be aware of hazards in the requirements include close distance color vision and focus of the RoleThis position will define and institutionalize a long-term robust automation program across three manufacturing sites. The leader in this role will ensure scalable compliant and technically advanced manufacturing systems capable of supporting complex fill-finish operations and combination productsJoin our One Team mission of manufacturing more tomorrows. Your expertise will help ensure better health and well-being for patients worldwide.# LI-Onsite