Senior Automation Manager

Posted Thursday, March 5, 2026 at 5:00 AMOur Work MattersAt Kindeva, we make products that save lives, ensuring better health and well-being for patients around the world.Why Kindeva?Collaborative team cultureDirect impact on patient careAt Kindeva, we make products that save lives, ensuring better health and well-being for patients around the world.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 levels of automation maturity. As the Senior Automation Manager, you will serve as the enterprise automation leader responsible for building a scalable, sustainable automation program that supports operational excellence, regulatory compliance, and long-term organizational growth.In this role, you will lead automation strategy for new facility stand-up, fill-finish and supporting equipment, automated visual inspection systems, auto-injector and device assembly automation, and packaging and serialization integration. You will oversee full lifecycle system ownership—from specification and implementation through validation and commercialization—while combining deep pharmaceutical automation expertise with strong organizational leadership to develop a high-performing automation function and future automation talent across the enterprise.Responsibilities:Enterprise 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 and new stand-up facility.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 AutomationAutomated visual inspection (AVI) for syringes and vials.Oversee cosmetic and particulate detection technologies.Reject the management and data capture system.Ensure inspection systems meet global regulatory and data integrity expectations.Lead 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.Integra te 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.Implement cross-training frameworks to ensure operational redundancy.Establish succession planning and competency development programs.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 guidance.Maintain audit readiness across automation systems and digital infrastructure.Partner with IT/OT to strengthen cybersecurity and system resilience.Qualifications:RequiredBachelor's degree in Engineering or related technical field. 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 in building and developing automation teams.Deep expertise in:Automated visual inspection (vials and syringes)Auto-injector assembly and device automationFormulation, filling, inspection, and packaging automation and serialization systemsMulti-site automation leadershipStrong experience in validation, commissioning, and commercialization support.Proven leadership experience in building and developing automation teams.Core CompetenciesPharmaceutical fill-finish automationCombination product and device assembly automationLifecycle validation and data integrityStrategic capital executionImpact 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 — including auto-injectors.Join our One Team mission of manufacturing more tomorrows. Your expertise will help ensure better health and well-being for patients worldwide.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.Do you see yourself as part of the Kindeva mission? Click Apply Now Today!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.Job Family B - Engineering - Automation EngineeringJ-18808-Ljbffr