Automation Engineer

AL Solutions; San Diego (CA); On-site; USD 100,000 - 140,000; Full time

Job summary

AL Solutions is seeking an Automation Engineer to own the automated systems across its biopharmaceutical manufacturing support operations. The role involves troubleshooting PLC/DCS/SCADA, maintaining validated controls, and delivering automation projects in a cGMP environment.

The candidate will collaborate with Manufacturing, Quality, IT, and Engineering teams, ensuring compliant documentation, risk-based change controls, and site readiness for commercial manufacturing.

Qualifications

• Bachelor's degree in a STEM discipline or equivalent relevant experience.
• Five or more years of systems administration, IT, controls, or automation experience.
• At least three years of automation experience within the pharmaceutical or biotechnology industry.
• Hands-on experience with Siemens automation platforms (S7, TIA Portal, PCS 7 or WinCC).
• Strong working knowledge of cGMP manufacturing requirements.
• Experience supporting automation in a regulated manufacturing environment.
• Familiarity with 21 CFR Part 11, GMP, and GxP requirements.
• Knowledge of industrial communication protocols like EtherNet/IP, BACnet, DeviceNet, and OPC UA.

Responsibilities

• Maintain, troubleshoot, repair, and upgrade PLC, DCS, SCADA, and networked automation systems.
• Provide automation engineering support for process, facility, utility, and building-management control systems.
• Design and specify automated control systems for manufacturing and facility applications.
• Support process data historians and automated biologics manufacturing platforms.
• Document system changes following change-control procedures.
• Support deviations, CAPAs, investigations, qualifications, and validations.

Skills

Industrial automation

Cross-functional collaboration

Documentation

Regulatory compliance

Education

Bachelor's degree in STEM

Tools

Siemens S7

TIA Portal

PCS 7

WinCC

EtherNet/IP

OPC UA

Job description

George Higginson is currently partnered with a leading biologics and bioconjugates CDMO that is strengthening its automation capabilities to support the continued growth and commercial readiness of its biopharmaceutical manufacturing operations.

As part of this growth, they are looking to hire an Automation Engineer. This is an excellent opportunity to join an established manufacturing organization and take ownership of the automated systems supporting its process, facility, and utility operations.

The Automation Engineer will provide hands‑on technical support for control systems used throughout cGMP biopharmaceutical manufacturing, including PLC, DCS, SCADA, data historian, processing, and building‑management systems.

You will work closely with Manufacturing, Engineering, Quality, IT, and other internal teams to troubleshoot systems, deliver automation projects, maintain validated control environments, and support the site’s progression toward commercial manufacturing.

Responsibilities:

• Maintain, troubleshoot, repair, and upgrade PLC, DCS, SCADA, and networked automation systems
• Provide automation engineering support for process, facility, utility, and building‑management control systems
• Design and specify automated control systems for manufacturing and facility applications
• Support process data historians and automated biologics manufacturing platforms
• Diagnose control‑system, instrumentation, hardware, software, and network‑related issues
• Author and review URS, FRS, SAT, IQ/OQ/PQ, CSV, and SOP documentation
• Document system modifications in accordance with established change‑control procedures
• Support deviations, CAPAs, investigations, qualifications, validations, and responses to audit observations
• Evaluate emerging automation technologies and recommend system improvements or upgrades
• Support automation activities associated with site and commercial readiness
• Partner cross‑functionally to resolve operational issues and successfully deliver assigned projects
• Maintain automation systems in accordance with cGMP, GxP, 21 CFR Part 11, and internal quality requirements
• Ensure work is performed safely and in compliance with applicable CAL/OSHA and regulatory requirements

Requirements:

• Bachelor’s degree in a STEM discipline or equivalent relevant experience
• Five or more years of systems administration, IT, controls, or automation experience
• At least three years of automation experience within the pharmaceutical or biotechnology industry
• Hands‑on experience with Siemens automation platforms, such as S7 PLCs, TIA Portal, PCS 7, or WinCC.
• Strong working knowledge of cGMP manufacturing requirements
• Proven experience supporting automation and control systems within a regulated manufacturing environment
• Experience troubleshooting and maintaining PLC, DCS, SCADA, and networked automation systems
• Knowledge of industrial communication protocols such as EtherNet/IP, BACnet, DeviceNet, and OPC UA
• Understanding of computerized system validation and validated control environments
• Familiarity with 21 CFR Part 11, GMP, and GxP requirements
• Experience supporting change controls, deviations, CAPAs, qualifications, and validation activities
• Demonstrated ability to independently troubleshoot complex technical and operational issues
• Strong project‑delivery, documentation, and cross‑functional communication skills
• Ability to build effective working relationships with colleagues, management, clients, and third‑party vendors

Preferred Experience:

• Automated biologics manufacturing platforms such as Sartorius BIOSTAT STR, Sartorius ambr, or Cytiva ÄKTA systems
• SCADA and data historian platforms such as Sartorius BioBrain Supervise, Sartorius BioPAT MFCS, or OSIsoft PI
• Siemens automation‑system design, programming, troubleshooting, or lifecycle management within pharmaceutical or biologics manufacturing.
• Process, facility, utility, or building‑management control systems
• Automation support for commercial or late‑stage biopharmaceutical manufacturing
• Controls engineering within biologics or bioconjugate manufacturing operations
• CDMO, client‑facing, or multi‑product manufacturing environments

Why This Role?

This is an opportunity to take a key technical position within a growing biologics CDMO, supporting the automated systems that enable the safe, reliable, and compliant manufacture of important biopharmaceutical products.

You will work across process automation, facility controls, data systems, and manufacturing equipment while playing an important role in troubleshooting operations, improving site capabilities, and supporting commercial readiness.