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 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