Director, Automation Engineering & CSV
Kindeva Drug Delivery, Bridgeton, MO, United States
Our Work Matters
At Kindeva, we make products that save lives, ensuring better health and well-being for patients around the world.
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 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.
Preferred Qualifications
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
Core Competencies
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
Physical Requirements
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.
Impact of the Role
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 products.
Equal Opportunity Employer:
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
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At Kindeva, we make products that save lives, ensuring better health and well-being for patients around the world.
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 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.
Preferred Qualifications
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
Core Competencies
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
Physical Requirements
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.
Impact of the Role
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 products.
Equal Opportunity Employer:
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
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