OverviewThe Automation Lead will be a key member of the Engineering Department and serve as the primary automation Subject Matter Expert (SME) for the sterile manufacturing facility. This role will be responsible for the design, implementation, commissioning, qualification, maintenance, and lifecycle management of automation and control systems supporting sterile manufacturing operations.
The primary scope of responsibility includes automation systems for sterile manufacturing equipment, Environmental Monitoring Systems (EMS), and automation of critical utility systems, including Water for Injection (WFI) generation and distribution, clean steam, compressed gases, and other applicable GMP utility systems. The Automation Lead will support the automation lifecycle from system design and vendor coordination through FAT, SAT, commissioning, qualification, start-up, routine operation, troubleshooting, cybersecurity, and continuous improvement.
This position is an individual contributor role with no direct reports.
ResponsibilitiesTechnical Oversight- Serve as the primary automation SME for the sterile manufacturing facility, including automation and control systems for sterile manufacturing equipment, Environmental Monitoring Systems (EMS), and GMP utility systems.
- Provide technical and engineering support throughout the automation lifecycle, including automation architecture and design review, software and hardware design, FAT, SAT, installation, commissioning, start-up, and routine operation.
- Develop and maintain in-depth knowledge of PLC, HMI, SCADA, DCS, Historian systems, industrial networks, data communication interfaces, control strategies, alarm management, and electronic data management applicable to assigned systems.
- Serve as the automation SME for critical utility systems, including WFI generation and distribution, clean steam, compressed air, nitrogen, and other applicable GMP utilities.
- Lead technical troubleshooting and root cause analysis for automation failures, control system issues, communication problems, alarms, and recurring equipment performance issues, and support implementation of effective corrective actions.
- Drive automation system reliability, performance optimization, lifecycle upgrades, backup and recovery strategies, alarm rationalization, and continuous improvement initiatives in collaboration with Manufacturing, Maintenance, IT, and other Engineering functions.
- Support product technology transfer and scale-up activities by ensuring appropriate automation recipes, control strategies, system interfaces, and electronic data requirements are established and maintained.
- As a member of the global engineering team, actively connect with and contribute to global automation and digital engineering projects, standards, planning, and implementation.
Technical Leadership- Provide technical guidance and coaching to automation engineers and other technical staff.
- Foster strong cross-functional collaboration with Manufacturing, Quality, Engineering, Supply Chain, and Program Management teams.
- Establish a culture of accountability, continuous improvement, technical excellence, and proactive problem solving.
- Support resource planning and workload prioritization to meet business and project objectives.
Regulatory Compliance- Ensure assigned automation systems and engineering activities are executed in compliance with cGMP requirements, applicable FDA requirements, EU GMP Annex 11, and internal quality standards.
- Review and approve automation-related technical documentation, including design specifications, protocols, reports, SOPs, change controls, and deviation investigations, as appropriate.
- Partner with Quality, Validation, IT/OT, Engineering, and Manufacturing to maintain the validated state and ongoing compliance of assigned automation and computerized systems.
Cross-Functional Collaboration and Technical Support- Act as a key technical interface between internal departments, equipment vendors, system integrators, and IT/OT to support efficient issue resolution and long-term system performance.
- Provide technical guidance and coaching to engineers, production technicians, and manufacturing support staff on automation systems and troubleshooting.
- Partner with Manufacturing, Quality, Validation, IT/OT, and Engineering to support system readiness, qualification, start-up, and sustained operation.
- Support development and execution of automation-related SOPs, technical procedures, and training.
- Support deviation investigations, CAPA implementation, change control assessments, and technical impact evaluations related to automation and computerized systems.
Qualifications- Excellent written and verbal communication skills, with strong attention to detail and clarity.
- Bachelor's or Master's degree in Automation Engineering, Electrical Engineering, Control Engineering, Computer Engineering, or a related technical discipline.
- Minimum of 5 years of experience in automation or controls engineering within the pharmaceutical, biotechnology, or other highly regulated manufacturing industries.
- Hands-on experience with industrial automation systems, including PLC, HMI, SCADA, DCS, Historian systems, industrial communication networks, and control system troubleshooting.
- Experience with automation systems supporting pharmaceutical manufacturing equipment and GMP utility systems is strongly preferred.
- Experience with automation design, FAT, SAT, commissioning, qualification, start-up, and lifecycle management of GMP computerized systems.
- Deep understanding of cGMP requirements, risk-based approaches, data integrity principles, and global regulatory expectations for computerized systems.
- Strong knowledge of applicable regulatory and industry expectations, including FDA 21 CFR Part 11, EU GMP Annex 11, GAMP principles, cybersecurity, and electronic records management.
- Proven experience supporting start-up or expansion of pharmaceutical or biotechnology manufacturing facilities is highly preferred.
- Demonstrated technical troubleshooting and problem-solving skills, with the ability to work effectively across Engineering, Manufacturing, Quality, Validation, IT/OT, and external vendors.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
