GMP QC Automation Specialist – Lab Systems Pro

CLS Services; Leiden; On-site; EUR 55,000 - 75,000; Full time

Job summary

Janssen Biologics in Leiden, Netherlands, seeks an Automation Specialist to serve as SME for automation in QC laboratories. The role covers data integrity, computerised systems, and robotics.

You will lead investigations of non-conformances across raw materials to drug product, perform root cause analyses, and coordinate CAPA actions. The position requires a HBO/BSc in Life Sciences or related field, 2+ years in GMP automation, and experience with systems like Empower, LIMS, Trackwise, and TECAN

Qualifications

• Bachelor's degree in Life Sciences, Computer Science, or equivalent.
• 2+ years in pharma GMP/automation role or similar.
• Solid knowledge of GMP regulations and FDA/EMA guidelines.

Responsibilities

• Lead investigations of non-conformances in testing of materials and products.
• Conduct root-cause analyses and coordinate CAPA actions.
• Oversee automation projects from standalone instruments to global platforms interfacing with LIMS.
• Ensure data integrity and compliance with 21 CFR Part 11 during audits.

Skills

GMP Compliance

Non-Conformance

Computer System Validation

Data Integrity

Education

Bachelor's degree in Life Sciences or Computer Science

Tools

Empower

LIMS

Trackwise

TECAN robotics

Job description

Janssen Biologics in Leiden, Netherlands, seeks an Automation Specialist to serve as SME for automation in QC laboratories. The role covers data integrity, computerised systems, and robotics.

You will lead investigations of non-conformances across raw materials to drug product, perform root cause analyses, and coordinate CAPA actions. The position requires a HBO/BSc in Life Sciences or related field, 2+ years in GMP automation, and experience with systems like Empower, LIMS, Trackwise, and TECAN