NL - Specialist 3, Validation

Job Role: Automation Specialist – QC Laboratories

About the Role: We are seeking an experienced Automation Specialist to support QC laboratories in a pharmaceutical environment. This role focuses on laboratory automation, computerized systems, data integrity and GMP compliance. You will act as a Subject Matter Expert (SME) for laboratory systems, supporting technical implementations, troubleshooting and system maintenance. You will also lead non-conformance investigations, perform root cause analysis and implement corrective and preventive actions (CAPA).

Key Responsibilities:

• Lead the technical implementation of laboratory systems, from standalone analytical instruments to complex platforms integrated with LIMS.

• Create and maintain technical installation, administration and maintenance procedures.

• Ensure data integrity, including backup strategies and disaster recovery planning.

• Provide technical support and troubleshoot computerized systems and laboratory automation issues.

• Ensure laboratory equipment and computerized systems comply with GMP and 21 CFR Part 11 requirements.

• Collaborate with cross-functional and global teams on laboratory systems projects.

• Lead investigations into non-conformances related to QC testing, raw materials, in-process materials, drug substance and drug product.

• Perform root cause analysis using tools such as 5 Whys, Fishbone diagrams and operator interviews.

• Define, coordinate and implement corrections, CAPAs and effectiveness checks.

• Act as a Subject Matter Expert during internal audits and external inspections.

• Support continuous improvement and LEAN initiatives across laboratory processes.

Key Competencies:

• Strong analytical thinking and technical problem-solving skills.

• Excellent documentation skills, with attention to data integrity and regulatory compliance.

• Proactive and independent, with the ability to take initiative and translate business needs into technical solutions.

• Strong communication and collaboration skills across different departments and organizational levels.

• Ability to manage priorities and support day-to-day laboratory operations.

• Excellent written and spoken English; Dutch is an advantage.

Requirements:

• Bachelor's degree (HBO) in Life Sciences, Computer Science or a related field, or equivalent relevant experience.

• Minimum of 2 years of pharmaceutical industry experience involving GMP and automation responsibilities.

• Hands-on experience with software development and programming.

• Experience with Computer System Validation (CSV) in a GxP environment.

• Understanding of GMP regulations, quality control procedures and relevant FDA and EMA guidelines.

• Experience with laboratory systems such as Empower, SoftMax Pro, SDMS, LIMS, 32Karat or TrackWise is an advantage.

• Knowledge of laboratory robotics, particularly TECAN, is desirable.

• Familiarity with GAMP 5, 21 CFR Part 11 and Lean/Six Sigma is a plus.

Practical Info:

• Location: Leiden, The Netherlands

• Duration: 1 year

• Work Model: Hybrid

• Employment Type: Full-time

• Start Date: ASAP

Interested or know someone who might be? Send your CV or inquiries to e.cabral@panda-int.com to apply or learn more.