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.As a Director of Automation & CSV, you will play a critical role in leading and standardizing pharmaceutical automation programs across three manufacturing sites of 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 commercialization.You 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 functions.ResponsibilitiesEnterprise Automation StrategyDevelop and execute a multi-year automation roadmap across three sites.Standardize controls architecture, PLC/HMI platforms, data systems, and automation governance.Establish a robust lifecycle management program aligned with GAMP and regulatory expectations.Lead modernization initiatives for legacy systems while ensuring minimal operational disruption.New Facility & Capital Project LeadershipLead automation strategy for major expansion projects.Own development and oversight of URS, FS, DS, FAT/SAT, commissioning, qualification, and PPQ support.Drive seamless integration from equipment procurement through validated commercial launch.Provide technical oversight during capital justification and vendor selection processes.Fill-Finish & Inspection AutomationProvide subject matter expertise in:Automated visual inspection (AVI) for syringes and vialsCosmetic and particulate detection technologiesReject management and data capture systemsEnsure inspection systems meet global regulatory and data integrity expectations.Auto-Injector & Combination Product AutomationLead automation oversight for auto-injector and specialty device assembly systems, including:Component feeding and orientationNeedle 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 requirements.Packaging, 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 requirements.Integrate packaging and serialization systems with enterprise data platforms.Lifecycle & Commercialization OwnershipProvide automation leadership from concept through commercialization.Partner with Validation and Quality to ensure compliant IQ/OQ/PQ execution.Drive automation reliability, performance monitoring, and OEE optimization.Implement structured change control and digital lifecycle documentation practices.Multi-Site Technical OversightHarmonize automation standards across three sites.Establish standardized spare parts strategy and obsolescence management.Provide escalation leadership for critical automation events.Define modernization roadmaps based on risk and operational impact.Organizational Development & Talent StrategyBuild and lead a high-performing automation engineering organization.Develop structured onboarding and certification pathways for new engineers.Implement cross-training frameworks to ensure operational redundancy.Establish a formal succession planning and competency development program.Create a sustainable staffing model balancing capital project demand and operational support.Compliance & Data IntegrityEnsure compliance with:21 CFR Part 11Annex 11GAMP 5 lifecycle standardsCombination product regulatory guidanceMaintain audit readiness across automation systems and digital infrastructure.Partner with IT/OT to strengthen cybersecurity and system resilience.Basic QualificationsBachelor's degree in Engineering or related technical field required; Master's degree preferred.10+ years of progressive pharmaceutical automation experience.Demonstrated success leading automation for new fill-finish or device manufacturing facilities.Strong experience in validation, commissioning, and commercialization support.Proven leadership experience building and developing automation teams.Preferred QualificationsDeep 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 procedures.Must wear all required PPE and perform assigned work in a safe manner.Must use proper lifting techniques and be aware of hazards in the environment.Vision requirements include: close, distance, color vision, and focus adjustment.Impact 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 products California residents should review our Notice for California Employees and Applicants before applying. Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees-regardless of format-without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.Equal Opportunity Employer:Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.Do you see yourself as part of the Kindeva mission? Click Apply Now Today!