
Posted a day ago
Principal Automation Engineer
AgilentPrincipal Automation Engineer
Requirements
Bachelor's or Master's degree, 10+ years relevant experience, Knowledge of GMP, GAMP, and GDP, Knowledge of 21CFR11 requirements, Knowledge of ISA-88, ISA/IEC 62443, ISA-95, and ISA-101 standards
Skills
PLCSCADAGMP
About the role
Responsibilities
- Function as the Automation Project Lead for large-scale greenfield manufacturing expansions
- Evaluate and recommend preferred automation integration platforms for new facilities
- Establish automation requirements for site process control, bioprocessing skids, and building management systems
- Define requirements for plant data historian systems, IT/OT infrastructure, and system integration
- Develop Manufacturing Execution System (MES) platform and integration requirements
- Coordinate MES and process data collection for Electronic Batch Records (EBR) implementation
- Manage contract resources for automation integration and system implementation
- Support Commissioning, Qualification, and Validation (CQV) activities as the primary automation point of contact
Requirements
- Bachelor's or Master's degree in a relevant field or equivalent experience
- 10+ years of relevant experience in automation engineering and leadership
- Deep knowledge of GMP, GAMP, and Good Documentation Practices (GDP)
- Strong understanding of 21CFR11 requirements and data integrity for biotech/pharmaceutical systems
- Proficiency with automation standards including ISA-88, ISA/IEC 62443, ISA-95, and ISA-101
- Knowledge of industrial control systems, networking, cybersecurity, and integrated architecture
- Excellent verbal and written communication skills for interacting with vendors and internal stakeholders
Preferred Qualifications
- Experience supervising personnel and coordinating group work activities
- Hands-on exposure to CSV, MES, DCS, PCS, SCADA, PLC, LIMS, EBR, QMS, and PDH
- Experience working in highly regulated industries with strict documentation requirements
- Proficiency with tools such as Agile PLM, MS Project, Smartsheet, or RAM CMMS
About the Company
Agilent is a global leader in life science, diagnostic, and applied market laboratories. We provide instruments, services, consumables, and expertise to help scientists and clinicians improve the world around them. Our Advanced Therapeutics Division operates as a contract development and manufacturing organization, providing critical products and services to improve health outcomes for patients worldwide.
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Agilent · Frederick
