Senior Automation Manager
About The Position
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 levels of automation maturity. As the Senior Automation Manager, you will serve as the enterprise automation leader responsible for building a scalable, sustainable automation program that supports operational excellence, regulatory compliance, and long-term organizational growth. In this role, you will lead automation strategy for new facility stand-up, fill-finish and supporting equipment, automated visual inspection systems, auto-injector and device assembly automation, and packaging and serialization integration. You will oversee full lifecycle system ownership—from specification and implementation through validation and commercialization—while combining deep pharmaceutical automation expertise with strong organizational leadership to develop a high-performing automation function and future automation talent across the enterprise.
Requirements
- Bachelor’s degree in Engineering or related technical field required; Master’s degree preferred.
- 7+ years of progressive experience in regulated manufacturing (pharma, med device, biotech)
- Demonstrated success leading automation in one or more of the following: fill‑finish, device assembly, packaging, automated inspection, or serialization.
- Strong Expertise in at least (one /two )major automation domain and familiarity with others
- 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
Responsibilities
- 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 one or more of the following areas, with the ability to support or develop capability in others over time: Automated visual inspection (AVI) for syringes and vials Cosmetic and particulate detection technologies Reject management and data capture systems
- Ensure systems meet applicable regulatory and data integrity expectations.
- Support or lead automation activities related to auto-injector and/or device assembly systems, which may include: 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 alignment with applicable combination product regulatory requirements.
- Provide automation support and/or leadership for packaging and serialization systems, including: Multi-carton configurations Blister packaging Specialty packaging for combination products Serialization and aggregation (unit through pallet)
- Ensure compliance with global track-and-trace requirements (e.g., DSCSA, EU FMD) as applicable.
- Support integration of packaging and serialization systems with site and enterprise data platforms.
- Provide automation leadership or support across the project lifecycle 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.
- Support harmonization of automation standards across sites, with opportunities to contribute to broader multi-site initiatives.
- Collaborate on spare parts strategies and obsolescence planning.
- Provide technical input and support for critical automation events as needed.
- Contribute to modernization planning based on business and operational priorities.
- Lead, mentor, or support automation engineers and technical teams, depending on project scope and organizational needs.
- Contribute to onboarding, training, and development of team members.
- Support knowledge sharing and cross-training to strengthen team capability.
- Participate in building a sustainable support model for both capital projects and ongoing operations.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
