Senior Automation Lead 1099/W2
About The Position
GMP Pros is 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 ControlLogix, and PlantPAx. The role oversees process-control system integrator coding and development, establishes programming standards, performs code reviews, and helps ensure solutions meet applicable GMP, validation, and data-integrity requirements. The position supports regulated pharmaceutical manufacturing automation projects and large-scale automation deployments. It includes work with drug product manufacturing operations and associated process and utility equipment, including vial filling and freeze-drying systems. The role also supports software development in regulated environments and Rockwell AssetCenter.
Requirements
- Bachelor of Science in Engineering, Automation, Computer Engineering, or a related technical discipline.
- At least 10 years of industrial automation experience.
- At least 5 years supporting pharmaceutical manufacturing automation projects.
- Demonstrated experience leading large-scale automation deployments in regulated pharmaceutical environments.
- Extensive experience developing pharmaceutical lifecycle documentation.
- Extensive experience with drug product manufacturing operations and associated process and supporting equipment.
- Experience supporting utility equipment, vial filling, and freeze-drying.
- Experience with software development in regulated environments and Rockwell AssetCenter.
- Knowledge of GAMP 5, USDA regulations, ALCOA+ data integrity, GDP, ISA-88, and ISA-95.
- Extensive ControlLogix experience with PlantPAx process libraries, including ladder logic, SFC, equipment phase programming, and PlantPAx library use.
- Extensive Ignition SCADA programming, configuration of its modules, and scripting of custom functions.
- Familiarity with Sepasoft Batch, including 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.
Responsibilities
- Provide technical leadership for Ignition SCADA, Sepasoft Batch, Rockwell ControlLogix, 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.
- Support automation for drug product manufacturing operations and associated process and utility equipment.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
