Lead Automation Engineer - Remote Opportunity (USA Based_

HW3; United States; Remote; USD 140,000 - 200,000; Full time

Job summary

Hw3 Llc is seeking a Lead Automation Engineer to drive complex automation programmes in life sciences. Remote work with up to 50% travel to customer sites, leading design, validation, and lifecycle management of manufacturing automation systems in GMP settings.

You will shape automation architecture, lead multi-disciplinary teams, and ensure cybersecurity, data integrity, and scalable solutions across DCS/PCS, MES, and data historians.

Qualifications

• Degree in Engineering or related discipline and 10+ years in regulated manufacturing.
• Experience leading automation projects from concept through handover.
• Strong client-facing and stakeholder management capabilities.

Responsibilities

• Provide technical leadership across design, implementation, validation, and lifecycle management of manufacturing automation systems.
• Lead commissioning, qualification activities and support regulatory inspections.
• Mentor engineers and collaborate with cross-functional teams to deliver compliant, scalable solutions.

Skills

Leadership

Client engagement

Industrial automation

Regulatory compliance

Project management

Education

Engineering degree

Tools

DeltaV DCS

Rockwell PlantPAx

FactoryTalk

SCADA/PLC systems

OSI PI (or similar)

Job description

Pharmaceutical Manufacturing | DeltaV | Rockwell | Digital Manufacturing

Location: Remote, with up to 50% travel requirement to customer sites.

Our client is a leading engineering and technology consultancy supporting global pharmaceutical, biotechnology, and advanced therapeutics manufacturers. Due to continued growth, they are seeking an experienced Lead Automation Engineer to drive complex automation programmes across a diverse portfolio of life sciences projects.

This is an excellent opportunity for a senior automation professional who enjoys technical leadership, client engagement, and delivering innovative manufacturing solutions within highly regulated environments.

The Opportunity

As a Lead Automation Engineer, you will provide technical leadership across the design, implementation, validation, and lifecycle management of manufacturing automation systems. You will work closely with clients and project teams to solve complex engineering challenges while ensuring project delivery, compliance, and operational excellence.

This role requires strong expertise in industrial automation platforms, manufacturing processes, and GMP-regulated environments, together with the ability to influence stakeholders and lead multidisciplinary teams.

Key Responsibilities

Automation Strategy & Architecture

• Design and develop automation solutions for pharmaceutical and biotechnology manufacturing facilities.
• DCS Platforms
• PLC/SCADA Systems
• Manufacturing Execution Systems (MES)
• Data Historians
• Process Instrumentation
• Create architecture diagrams and integration strategies aligned with ISA-88 and ISA-95 principles.
• Ensure solutions support scalability, cybersecurity, data integrity, and operational flexibility.

Lead or review the development of:

• User Requirement Specifications (URS)
• Functional Requirement Specifications (FRS)
• Design Specifications (DS/DDS)
• Functional & Control Narratives
• Batch Recipe Documentation

Translate manufacturing and process requirements into robust automation designs and technical deliverables.

System Implementation

• Configure, develop, and deploy automation applications.
• Support DeltaV DCS implementations including:
• Modules
• Phases
• Batch Logic
• Recipes
• Operator Graphics
• Alarm Management
• Develop and modify Rockwell Automation solutions including:
• ControlLogix
• CompactLogix
• PlantPAx
• FactoryTalk
• SCADA/HMI Platforms
• Integrate process equipment and utility systems into manufacturing control environments.

Validation & Regulatory Compliance

• Lead commissioning and qualification activities.
• Support FAT, SAT, IQ, OQ, and PQ execution.
• Ensure automation systems meet GMP requirements, data integrity standards, and validation lifecycle expectations.
• Lead investigations, CAPA activities, risk assessments, and change management processes.
• Support regulatory inspections and quality audits.

Operational Support & Continuous Improvement

• Act as a technical escalation point for complex automation issues.
• Lead troubleshooting, root cause analysis, and performance improvement initiatives.
• Optimise batch execution, alarm management, and system reliability.
• Develop long-term lifecycle strategies including upgrades, migrations, and system modernisation activities.

Leadership & Stakeholder Engagement

• Provide technical guidance to engineering teams.
• Mentor and support junior and mid-level engineers.
• Collaborate with manufacturing, quality, validation, engineering, and IT/OT stakeholders.
• Manage relationships with system integrators, equipment suppliers, and external partners.
• Drive project execution while maintaining high standards of technical quality and customer satisfaction.

Skills & Experience Required

Education

• Degree qualified in Engineering, Automation, Electrical Engineering, Chemical Engineering, Mechanical Engineering, or a related discipline.

Experience

• 10+ years of industrial automation experience within regulated manufacturing environments.
• Significant experience supporting biotechnology, pharmaceutical, sterile manufacturing, or advanced therapy facilities.
• Proven track record of leading automation projects from concept through operational handover.

Technical Expertise

Strong experience in:

• PLC & SCADA Systems
• Distributed Control Systems (DCS)
• Manufacturing Execution Systems (MES)
• Data Historians (OSI PI or similar)
• Digital Manufacturing Platforms

Industry Knowledge

Working knowledge of:

• ISA-88
• ISA-95
• GAMP 5
• GMP Manufacturing
• Data Integrity Principles
• Validation Lifecycle Activities
• Sterile and Aseptic Manufacturing Operations

Preferred Experience

• Previous experience within engineering consulting, system integration, or project-based delivery environments.
• Strong client-facing and stakeholder management skills.
• Advanced troubleshooting and analytical capabilities.
• Experience managing technical scope, project changes, and competing priorities.
• Demonstrated mentoring and leadership ability.
• Excellent communication and presentation skills.