Biopharma Manufacturing Systems Lead (GMP)

WuXi Biologics; Dundalk; On-site; EUR 90,000 - 120,000; Full time

Job summary

WuXi Biologics Ireland is seeking a Manufacturing Systems Lead to establish and lead the Manufacturing Systems team within the Manufacturing Operations group in Dundalk. You will provide expert support across SAP, LIMS, TrackWise and Orchestrate, acting as the owner of SAP Production Planning and coordinating benchtop equipment qualification lifecycle.

The role requires 5+ years in biopharmaceutical manufacturing, strong leadership, and experience with GMP systems and regulatory expectations.

Qualifications

• BSc, MSc or PhD in Chemical Engineering, Bioscience, Biotechnology or Analytical Science.
• Experience with FDA/EMA/CFDA quality systems (Deviation, Investigation, CAPA, Change Control).
• Experience with electronic batch records is advantageous.

Responsibilities

• Provide expert support to Manufacturing with SAP, LIMS, TrackWise and finite scheduling.
• Act as business owner for SAP Production Planning.
• Oversee benchtop equipment qualification lifecycle and maintenance.
• Collaborate with MT and MSAT on technical transfer and process validation.
• Support GMP compliance, deviations, CAPA, and client inspections.

Skills

SAP

LIMS

Orchestrate

TrackWise

GMP

Team leadership

Budgeting

Education

BSc/MSc/PhD in Chemical Engineering / Bioscience / Biotechnology / Analytical Science

Tools

Orchestrate scheduling software

SAP Production Planning

Job description

WuXi Biologics Ireland is seeking a Manufacturing Systems Lead to establish and lead the Manufacturing Systems team within the Manufacturing Operations group in Dundalk. You will provide expert support across SAP, LIMS, TrackWise and Orchestrate, acting as the owner of SAP Production Planning and coordinating benchtop equipment qualification lifecycle.

The role requires 5+ years in biopharmaceutical manufacturing, strong leadership, and experience with GMP systems and regulatory expectations.