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.

• 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.

• 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.

• 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

• 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

• Employees are required to follow all cGMP and safety procedures.
• Must wear all required PPE and perform assigned work in a safe manner.
• Must use proper lifting techniques and be aware of hazards in the environment.
• Vision requirements include: close, distance, color vision, and focus adjustment.

This 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…