Senior Automation Lead

GMP Pros®; Kansas; On-site; USD 120,000 - 180,000; Full time

Job summary

GMP Pros® is seeking a Senior Automation Lead in the United States to provide technical leadership for Ignition SCADA, Sepasoft Batch, Rockwell ControlLogix, and PlantPAx solutions within a GMP environment.

You will define automation standards, review designs from system integrators, and coordinate validation activities such as IQ/OQ/PQ to ensure data integrity and compliance.

Qualifications

• BS in engineering or automation-related discipline.
• 7–10+ years industrial automation experience.
• Pharma/regulated environments experience preferred.
• Experience leading large-scale automation deployments.

Responsibilities

• Provide technical leadership for Ignition SCADA, Sepasoft Batch, Rockwell ControlLogix, and PlantPAx.
• Define and enforce automation programming and configuration standards.
• Review designs and code from system integrators and programmers.
• Lead integration of process-control systems with OEM equipment.
• Support data historization, SQL databases, and IT/OT network architecture.
• Oversee QC/validation activities: IQ/OQ/PQ, FAT/SAT, and testing.
• Manage software versioning and change controls.
• Create and review lifecycle validation documentation (URS, FS, SDS/HDS).

Skills

Ignition SCADA

Sepasoft Batch

Rockwell ControlLogix

PlantPAx

GAMP5

S88/S95

Data integrity (ALCOA+)

PLC programming

Automation standards

Education

BS in Engineering

BS in Automation or related field

Tools

SQL databases

AssetCenter

IT/OT networking

Job description

Do you need variety and change to keep from getting bored?

Do you build relationships easily and are you able to communicate information so that it is easily understandable?

Do you like working in a team supportive environment where others want to help you succeed?

Do you try to find a better way for everything because that is the way it should be?

Do you thrive in organized chaos and high-pressure situations?

Do you quickly become an expert in any subject matter you are working in?

Can you stay motivated and help motivate others in the face of adversity and change? Are you resilient?

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 ControlLogix, 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.

The Essential Duties:

• 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.

Here are the requirements for the skilled professionals we are looking for:

• BS in Engineering, Automation, Computer Engineering, or a related technical discipline.
• Minimum of 7-10+ 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.

Some other things that you will need to be successful:

• 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 AssetCenter.
• 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 ControlLogix 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.

Pre-Employment Requirements:

• Pass and maintain pre-employment background check and safety certification, including but not limited to outstanding professional references
• Subject to motor vehicle report review.
• Maintain valid driver’s license and endorsements as required per position.
• Pass pre-employment physical, medical evaluation, and drug screen due to the safety sensitive nature of this position.
• Successfully complete and maintain any required safety certification and testing on an annual basis.

Key Words :Ignition SCADA, Sepasoft Batch, ControlLogix, PlantPAx, S88, S95, GAMP5, CSV, drug product, vial filling, freeze drying, FAT, SAT, IQ/OQ/PQ, ALCOA+, AssetCenter, SQL, IT/OT