Lead Automation Engineer, MES – Digital Systems

This is a fully remote position, open to applicants in Alabama, +15 more states.

📋 Description

• Deliver subject matter expertise in the design, execution, and lifecycle management of digital systems across biologics, pharmaceutical, and novel therapy manufacturing sites.

• Create system architectures and data flows for biologics, pharmaceutical, and advanced therapy manufacturing (DCS, PLC/SCADA, MES, historians, network layers).

• Formulate product recipe strategies encompassing the entire application layer of ERP, MES, and DCS Batch.

• Generate ISA-88/ISA-95-compliant architecture documentation.

• Ensure that architecture facilitates scalability, cybersecurity, data integrity, and flexibility for multiple products.

• Oversee documentation processes such as URS, FRS, DS, and various design specifications.

• Configure, program, and implement Digital Systems within the manufacturing environment.

• Offer manufacturing operations support through troubleshooting and optimization efforts.

• Work collaboratively across various teams to deliver integrated system solutions.

• Guide junior engineers and serve as a technical subject matter expert during audits and regulatory inspections.

⛳️ Requirements

• Bachelor’s degree in Engineering (Automation, Electrical, Chemical, Mechanical, or a related field).

• A minimum of 9-12+ years of experience in automation engineering within GMP life sciences (biotech, pharma, ATMP).

• Expert-level proficiency with various MES platforms, Data Repositories, Serialization, and integration with manufacturing applications (ERP, LIMS, CMMS, etc).

• Demonstrated ability to author, interpret, and manage URS/FRS/DS documentation.

• Experience in designing system applications and data flows across a wide range of manufacturing applications.

• Strong comprehension of ISA-88 batch control, ISA-95 manufacturing hierarchy, and GAMP 5.

• Practical experience supporting biologics and sterile/aseptic manufacturing environments.

• Candidates must be authorized to work in the United States on a full-time basis.

• This position may necessitate significant travel to meet project and business requirements.

• Knowledge of multisite standards for global manufacturers.

🏝️ Benefits

• Health insurance

• 401(k) plan

• Flexible work arrangements

• Professional development opportunities