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Senior Automation Manager

Job in Maryland Heights, St. Louis city, Missouri, 63043, USA
Listing for: Kindeva Drug Delivery
Full Time position
Listed on 2026-03-08
Job specializations:
  • Engineering
    Automation Engineering, Systems Engineer
Salary/Wage Range or Industry Benchmark: 80000 - 100000 USD Yearly USD 80000.00 100000.00 YEAR
Job Description & How to Apply Below
Location: Maryland Heights

Posted Thursday, March 5, 2026 at 5:00 AM

Our Work Matters

At Kindeva, we make products that save lives, ensuring better health and well-being for patients around the world.

Why Kindeva?
  • Collaborative team culture
  • Direct impact on patient care

At 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 Strategy
  • Develop 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 Leadership
  • Lead 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 Automation
  • Automated 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 orientation
    • Needle safety system integration
    • Plunger rod insertion and final device assembly
    • Functional device testing (force, timing, deployment verification)
    • Traceability and tamper-evident integration
  • Ensure compliance with combination product regulatory requirements.
Packaging, Serialization & Specialty Packaging
  • Oversee packaging automation platforms, including:
    • Multi-carton configurations
    • Blister packaging
    • Specialty packaging for combination products
    • Auto-injector final pack-out systems
    • Serialization 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 Ownership
  • Provide 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 Oversight
  • Harmonize 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 Strategy
  • Build and lead a high-performing automation engineering organization.
  • Develop structured onboarding and certification pathways.
  • Implement cross-training frameworks to ensure operational…
Position Requirements
10+ Years work experience
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