Director, Automation Engineering & CSV

The Impact You Will Make

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 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.

Responsibilities

• Standardize controls architecture, PLC/HMI platforms, data systems, and automation governance.
• Establish a robust lifecycle management program aligned with GAMP and regulatory expectations.
• Led modernization initiatives for legacy systems while ensuring minimal operational disruption.
• Lead automation strategy for major expansion projects.
• Owning 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:
• Automated visual inspection (AVI) for syringes and vials
• 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
• Blisters 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 strategies 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.
• Create 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.

Qualifications

• Required: 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 in building and developing automation teams.
• PREFERRED: 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

Physical Requirements

• Follow all cGMP and safety procedures.
• Wear all required PPE and perform assigned work in a safe manner.
• Use proper lifting techniques and be aware of hazards in the environment.
• Vision requirements include close, distance, color vision, and focus adjustment.