Automation & QC Systems Specialist (GMP/LIMS)

eTeam; Leiden; Hybrid; EUR 60,000 - 90,000; Full time

Job summary

eTeam in Leiden, the Netherlands, is seeking an Automation Specialist to support GMP QC laboratories. The role serves as SME for automation topics, ensuring data integrity and regulatory compliance, and driving LEAN improvements.

The position focuses on investigating non-conformances, implementing CAPA, and coordinating with global teams. Requires a GMP background, 2+ years in pharma, and BS in Life Sciences or CS. Hybrid work setup in the Leiden area is offered.

Qualifications

• Bachelor’s degree in Life Sciences or Computer Science or equivalent.
• Minimum 2 years in pharma with GMP and automation responsibilities.
• Hands-on software development background; laboratory experience a plus.
• Experience with Computer System Validation in a GxP environment.
• Excellent English written and spoken; Dutch desirable.

Responsibilities

• Lead technical implementation of lab systems and LIMS interfaces.
• Create and maintain administrator, installation, and maintenance procedures.
• Own data integrity practices including backup and recovery planning.
• Provide timely support and troubleshooting for computerized systems.
• Ensure 21 CFR Part 11 compliance for equipment implementations.
• Lead investigations of non-conformances and define CAPAs.
• Participate in internal audits and external inspections as needed.
• Collaborate with cross-functional teams to align with business needs.

Skills

Analytical thinking

GxP knowledge

Quality assurance

Data integrity

Problem solving

English proficiency

Cross-functional collaboration

Laboratory automation

Programming basics

Proactive mindset

Education

Bachelor’s degree in Life Sciences/Computer Science

Tools

Empower

Softmax Pro

SDMS

LIMS

Trackwise

32Karat

Deskman

TECAN

Job description

eTeam in Leiden, the Netherlands, is seeking an Automation Specialist to support GMP QC laboratories. The role serves as SME for automation topics, ensuring data integrity and regulatory compliance, and driving LEAN improvements.

The position focuses on investigating non-conformances, implementing CAPA, and coordinating with global teams. Requires a GMP background, 2+ years in pharma, and BS in Life Sciences or CS. Hybrid work setup in the Leiden area is offered.