Biopharma Process Engineer, CQV & TechOps (GMP)

WuXi Biologics; Dundalk; On-site; EUR 60,000 - 80,000; Full time

Job summary

WuXi Biologics in Dundalk, Ireland invites a Process Engineer to join the Manufacturing Technology team. You will provide engineering support for Manufacturing 6 & 7 and assist with tech transfer projects into these facilities.

The role reports to the TechOps Team Lead and involves QA/QA-regulated activities across equipment validation, verification, and commissioning. Key tasks include assisting startup efforts, coordinating vendor documentation, writing validation protocols, supporting FAT/CQV

Qualifications

• Third level qualification in a Science or Engineering related subject is preferable.
• Experience with GMP compliant documentation and record keeping is beneficial.
• Familiarity with validation and commissioning processes is advantageous.

Responsibilities

• Assist in site startup and project-related activities.
• Support vendor management and equipment/ process queries.
• Generate equipment verification & validation protocols and reports.
• Participate in FAT and CQV activities and commissioning.
• Ensure equipment is validated and maintained in a validated state.

Skills

cGMP knowledge

DeltaV MCS

Chromatography

Equipment troubleshooting

Documentation

Education

Bachelor's degree in Science or Engineering

Tools

DeltaV MCS Software

MS Office

Job description

WuXi Biologics in Dundalk, Ireland invites a Process Engineer to join the Manufacturing Technology team. You will provide engineering support for Manufacturing 6 & 7 and assist with tech transfer projects into these facilities.

The role reports to the TechOps Team Lead and involves QA/QA-regulated activities across equipment validation, verification, and commissioning. Key tasks include assisting startup efforts, coordinating vendor documentation, writing validation protocols, supporting FAT/CQV