Senior Automation Lead 1099​/W2

What does it mean to be an Automation Engineer with GMP Pros? We are seeking an experienced Senior Automation Lead to provide technical leadership for the design, development, integration, testing, and qualification of solutions built around Ignition SCADA, Sepasoft Batch, Rockwell Control Logix, and PlantPAx. This position will provide oversight of the process control system integrator coding and development, establish programming standards, perform code reviews, ensure solutions, meet applicable GMP, validation, and data-integrity.

• Provide technical leadership for Ignition SCADA, Sepasoft Batch, Rockwell Control Logix, and PlantPAx solutions.
• Define and enforce automation programming and configuration standards.
• Review PLC, SCADA, and batch application designs and code developed by system integrators and other programmers.
• Lead integration of process-control systems with OEM equipment and supporting systems.
• Support data historization, reporting, SQL databases, and IT/OT network architecture.
• Support module testing, integration testing, FAT, SAT, IQ/OQ, and PQ activities.
• Oversee software version management and project software change control.
• Author, review, and approve automation lifecycle and validation documentation, including URS, FS, SDS/HDS, risk assessments, test protocols,
• traceability matrices, and validation reports.

• BS in Engineering, Automation, Computer Engineering, or a related technical discipline.
• Minimum of 10+ years of industrial automation experience.
• Minimum 5+ years supporting pharmaceutical manufacturing automation projects.
• Demonstrated experience leading large-scale automation deployments in regulated pharmaceutical environments.
• Extensive experience with all pharmaceutical life cycle documentation development.
• Extensive experience with all DP manufacturing operations and all associated process and supporting process and utilities equipment.

• Extensive GAMP5 and pharmaceutical life cycle documentation development; extensive experience with DP manufacturing operations and the associated process.

• Experience supporting utilities equipment (vial filling and freeze-drying; software development in regulated environments and Rockwell Asset Center.

• Knowledge of USDA regulations, ALCOA+ data integrity, GDP, ISA-88, and ISA-9, GDP, ISA-88, and ISA-95.

• Most systems in the plan use Control Logix with the PlantPAx process library: ladder, SFC and equipment phase programming, with extensive PlantPAx library use.

• The SCADA platform is Ignition: extensive Ignition SCADA programming, configuration of all modules, and scripting of custom functions.

• Familiarity with Sepasoft Batch: configuration of all Sepasoft batching objects and models, procedure and unit procedure development, track and trace, and recipe development to S88/S95.

• Knowledge of SCADA/PLC interfacing to OEM equipment, data historization, reports, SQL databases and scripting, and IT/OT network design and architecture.

Ignition SCADA, Sepasoft Batch, Control Logix, PlantPAx, S88, S95, GAMP5, CSV, drug product, vial filling, freeze drying, FAT, SAT, IQ/OQ/PQ, ALCOA+, Asset Center, SQL, IT/OT