Director, Automation Engineering & CSV

Kindeva • Bridgeton, MO

1d • Onsite

About The Position

At 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.

Requirements

• Bachelor’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.

Nice To Haves

• 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.

Responsibilities

• 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.
• Lead 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.
• Provide subject matter expertise in: Automated visual inspection (AVI) for syringes and vials, Cosmetic and particulate detection technologies, Reject management and data capture systems.
• 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.
• 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.
• 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.
• 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.
• Build 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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director