GMP Automation Engineer: Systems Reliability and Compliance

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

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.