Senior Automation Manager

Kindeva Drug Delivery•Maryland Heights, MO

20h•Onsite

About The Position

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. .

Requirements

Bachelor’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 automation
Formulation, filling, inspection, and packaging automation and serialization systems
Multi-site automation leadership
Strong experience in validation, commissioning, and commercialization support.
Proven leadership experience in building and developing automation teams.
Pharmaceutical fill-finish automation
Combination product and device assembly automation
Packaging & serialization integration
PLC, SCADA, HMI, MES architecture
Lifecycle validation and data integrity
Multi-site standardization
Organizational development & succession planning
Strategic capital execution

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 Provide subject matter expertise in: 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.
Auto-Injector & Combination Product Automation 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.
Integrate 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 redundancy.
Establish succession planning and competency development programs.
Create a sustainable staffing model balancing capital project demand and operational support.
Compliance & Data Integrity Ensure compliance with: 21 CFR Part 11
Annex 11
GAMP 5 lifecycle standards
Combination product regulatory guidance.
Maintain audit readiness across automation systems and digital infrastructure.
Partner with IT/OT to strengthen cybersecurity and system resilience.