Director, Automation Engineering & CSV

Our Work Matters
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.
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.
- 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
- Cosmetic and particulate detection technologies
- Reject management and data capture systems
- 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 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 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.
Basic Qualifications
- Bachelor’s degree in Engineering or related technical field required; Master’s degree preferred.
- 10+ years of progressive pharmaceutical automation experience.
- Demonstrated success leading