AIS Engineer (PLC)

WuXi Biologics; Dundalk; On-site; EUR 60,000 - 85,000; Full time

Benefits offered by this job

Equal opportunities employer

Job summary

WuXi Biologics in Dundalk, Ireland, seeks an Automation Engineer to support and enhance automation systems across the site. You will apply GMP, maintain system reliability, and lead lifecycle improvements while collaborating with manufacturing, engineering, IT and external vendors.

You will review URS, SDS and SOPs, support new product introductions, and ensure data integrity and regulatory compliance. A 3–5+ year background in regulated environments is preferred.

Qualifications

• Bachelor's degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering or related technical discipline.
• 3–5+ years of relevant industry experience preferred.
• Experience in pharma/biotech regulated manufacturing.
• Familiarity with GMP, data integrity and 21 CFR Part 11.

Responsibilities

• Own and administer automation systems in a GMP environment.
• Execute improvements, change control, configuration updates and lifecycle management.
• Troubleshoot controls, instrumentation and networked automation issues.
• Develop URS, SDS, design docs and SOPs as required.
• Support new product introductions and automation assessments.
• Ensure compliance with GAMP, ISA-88/95 and data integrity requirements.
• Maintain system reliability through preventive maintenance and backups.
• Collaborate with manufacturing, engineering, utilities, quality, IT and vendors.

Skills

Automation systems

GMP compliance

Problem solving

Stakeholder management

Team collaboration

Education

Bachelor's degree in Electrical Engineering; Computer Science; Chemical Engineering; Biotech Engineering or related technical discipline

Tools

SCADA

PLC systems

ISA-88/95

Job description

The Automation Engineer is responsible for supporting, maintaining and improving automation systems across the site. The individual will provide technical expertise, ensure system reliability, develop automation strategies, support new technology introductions, and act as a system owner in accordance with GMP, site procedures and corporate standards.

Essential Duties and Responsibilities

• System ownership and administration of assigned automation systems in a GMP environment
• Execution and support of system improvements, change control, configuration updates and lifecycle management
• Troubleshooting, technical root cause analysis and resolution of issues related to controls, instrumentation, networked automation, software and hardware
• Development and review of URS, SDS, design documentation, specifications and SOPs as required
• Support for new product introductions and engineering studies, including automation assessments and configuration changes
• Ensure compliance with GAMP, applicable standards (e.g. ISA-88, S95), data integrity and 21 CFR Part 11 requirements
• Maintain system reliability through preventive maintenance, patching, backups and disaster recovery processes
• Support operational readiness and continuous improvement initiatives across automation platforms
• Collaboration with manufacturing, engineering, utilities, quality, IT and external vendors
• Perform duties in accordance with GMP, safety standards and site policies
• Flexibility to take on additional responsibilities as assigned by the AIS Lead
• Will act as a role model for the Engineering function and also the wider organisation in adherence to the
• WuXi corporate core values and PROUD culture.
• Strong understanding of industrial automation systems, control platforms and instrumentation
• Ability to interpret automation documentation including P&IDs, network diagrams, design specifications and validation documents
• Familiarity with automation lifecycle management, change control and validation principles
• Knowledge of industry standards including GAMP, ISA-88/95, and data integrity requirements
• Understanding of network fundamentals, cybersecurity principles and integration concepts
• Ability to diagnose complex equipment, software and control issues

Experience

• Experience in a pharmaceutical, biotechnology or regulated manufacturing environment
• Hands-on experience supporting automation, control systems, equipment integrations, instrumentation or
• Experience with troubleshooting, system administration, commissioning, qualification and change control

Knowledge

• Knowledge of GMP operations and regulatory expectations for automated systems
• Understanding of automated equipment, batch systems, utilities, networked assets, or virtualised environments (depending on sub-function)

Qualifications

• Bachelor's degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering or related technical discipline
• 3-5+ years relevant industry experience preferred
• Independent, self-directed, well-organised and capable of managing multiple priorities
• Strong communication, collaboration and stakeholder management skills
• Problem-solving mindset with a focus on compliance, reliability and continuous improvement
• Demonstrates integrity and adherence to procedures, standards and regulatory obligations

WuXi Biologics is an equal opportunities employer.