Senior Automation Engineer - Remote Opportunity - (USA Based)

HW3; United States; A distancia; USD 110.000 - 170.000; Jornada completa

Descripción de la vacante

Hw3 Llc is seeking a Senior Automation Engineer to design, implement, and support complex automation systems for pharmaceutical and biotechnology production environments. You will lead technical initiatives, mentor junior engineers, and drive projects from concept through validation and operation.

You will guide architecture decisions for DCS/PLC/SCADA, MES, and data historians, ensuring scalable, secure, and compliant solutions while coordinating with process, quality, and IT teams.

Formación

• Bachelor's degree in Engineering or related technical discipline.
• 5+ years delivering automation solutions within regulated manufacturing environments.
• Experience in pharmaceutical, biotechnology, cell & gene therapy, or GMP-regulated industries.

Responsabilidades

• Design, implement, and support advanced automation systems in pharma/biotech environments.
• Provide technical leadership and mentor junior engineers across project lifecycles.
• Develop automation architectures (DCS/PLC/SCADA, MES) and integration strategies.
• Lead FAT, SAT, IQ/OQ/PQ activities and ensure GMP/compliance adherence.
• Collaborate with cross-functional teams to optimize manufacturing performance.

Conocimientos

Technical leadership

Communication skills

Troubleshooting

Mentoring

Project management

Documentation

Educación

Bachelor's degree in Engineering

Descripción del empleo

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

• Other leading industrial automation platforms

MES & Digital Manufacturing

• Manufacturing Execution Systems
• Production data repositories and historians
• ERP, LIMS, CMMS, and enterprise system integrations
• Digital manufacturing initiatives
• Building Management Systems (BMS)
• Industrial utility automation platforms

Industry Knowledge

Working knowledge of:

• ISA-88
• ISA-95
• GAMP 5
• 21 CFR Part 11
• Industrial cyber security principles
• GMP manufacturing and validation practices

Desired Skills

• Strong technical leadership capabilities.
• Excellent communication and stakeholder engagement skills.
• Advanced troubleshooting and root cause analysis expertise.
• Ability to manage multiple projects and priorities simultaneously.
• Experience mentoring engineers and developing technical teams.
• Strong organisational, planning, and documentation skills.
• Commercial awareness and client-facing experience.