Senior Automation Engineer - Remote Opportunity - (USA Based)

Hw3 Llc

United States

Remote

USD 110,000 - 170,000

Full time

33 hours ago

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Job summary

Hw3 Llc is seeking a Senior Automation Engineer to join its life sciences manufacturing practice. Remote with travel to client manufacturing facilities as required (up to 50%), you will design, implement, and support complex automation systems used in GMP pharma and biotech environments.

You will lead technical workstreams, mentor junior engineers, and collaborate with process, quality, validation, IT/OT teams to deliver scalable, compliant solutions from concept through commissioning and

Qualifications

Bachelor's degree in Engineering or related technical discipline.
5+ years delivering automation solutions in regulated manufacturing.
Experience leading technical workstreams and complex system implementations.

Responsibilities

Develop automation architectures for manufacturing facilities (DCS/PLC/SCADA, MES, historians).
Lead validation activities (FAT/SAT/IQ/OQ/PQ) and ensure GMP compliance.
Mentor engineers and manage relationships with clients and vendors.
Support system upgrades, integrations, and lifecycle optimisation.

Skills

Leadership

Communication

Troubleshooting

Project management

Education

Bachelor's degree in Engineering or related field

Job description

Life Sciences Manufacturing | DCS, PLC, MES & OT Systems

Location: Remote with travel to client manufacturing facilities as required (up to 50%).

About the Opportunity

A growing engineering and consulting organisation supporting pharmaceutical, biotechnology, and advanced therapy manufacturers is seeking a Senior Automation Engineer to join its digital and automation team.

This position is ideal for an experienced automation professional who enjoys leading complex technical initiatives, developing automation strategies, and delivering innovative solutions within regulated manufacturing environments.

You will work with cross-functional teams throughout the project lifecycle, from concept design and system architecture through implementation, commissioning, validation, and operational support.

The Role

As a Senior Automation Engineer, you will act as a technical subject matter expert responsible for designing, implementing, and supporting complex automation systems used in pharmaceutical and biotechnology production environments.

You will provide technical leadership, guide project execution, mentor junior engineers, and help clients optimise manufacturing performance through modern automation technologies

Key Responsibilities

Develop automation architectures for manufacturing facilities, including:
Distributed Control Systems (DCS)
PLC/SCADA Platforms
Manufacturing Execution Systems (MES)
Data Historians
Field Instrumentation
Create system architecture diagrams aligned with ISA-88 and ISA-95 principles.
Define network structures, interface requirements, data flows, and integration strategies.
Ensure solutions support scalability, cybersecurity, operational flexibility, and data integrity.

Automation Documentation

Lead or contribute to the development and review of:

User Requirement Specifications (URS)
Functional Requirement Specifications (FRS)
Design Specifications (DS/DDS)
Functional and Control Narratives
Batch Recipe Documentation
Automation Standards and Engineering Guidelines

Work closely with process and manufacturing teams to translate operational requirements into practical automation solutions.

System Development & Deployment

Configure, program, test, and deploy automation systems.
Develop and support:
Control Modules
Equipment Modules
Batch Logic
Recipes
HMI Graphics
Alarm Strategies
Support integration of process and facility equipment, including production skids, utilities, HVAC systems, and support infrastructure.
Participate in system upgrades, migrations, and modernisation initiatives.

Validation & Compliance

Lead and support FAT, SAT, IQ, OQ, and PQ activities.
Ensure solutions comply with GMP requirements, data integrity principles, and industry best practices.
Participate in risk assessments, deviation investigations, CAPA activities, and change management processes.
Support audit readiness and regulatory inspections.

Manufacturing Support & Optimisation

Act as the technical escalation point for automation-related issues.
Lead troubleshooting and root cause investigations.
Optimise system performance, reliability, alarm management, and batch execution.
Develop long-term lifecycle strategies for automation platforms and infrastructure.

Leadership & Stakeholder Management

Collaborate with engineering, manufacturing, quality, validation, and IT/OT teams.
Manage relationships with system integrators, software vendors, and equipment suppliers.
Review technical deliverables and ensure alignment with project requirements and engineering standards.
Mentor and support junior engineers.
Provide technical leadership across project teams and client engagements.

Required Qualifications

Education

Bachelor's degree in Engineering, Automation, Electrical Engineering, Computer Engineering, Chemical Engineering, Life Sciences, or a related technical discipline.
Equivalent industry experience may also be considered.

Experience

5+ years of experience delivering automation solutions within regulated manufacturing environments.
Proven experience supporting pharmaceutical, biotechnology, cell & gene therapy, or other GMP-regulated industries.
Experience leading technical workstreams and managing complex system implementations.

Technical Expertise

Strong experience in one or more of the following areas:

DCS / PLC / SCADA