automation Specialist

Johnson & Johnson | Leiden (Hybrid) | 1 year contract

We're currently supporting Johnson & Johnson in Leiden in the search for an experienced NC Automation Specialist to join their Quality Control organisation. This role offers the opportunity to work at the intersection of laboratory automation, compliance, quality investigations, and computerized systems within a highly regulated GMP environment.

As the subject matter expert for automation-related quality events and laboratory systems, you will support both operational activities and strategic initiatives across the QC organisation. Working closely with laboratory, quality, engineering, and global stakeholders, you'll help ensure system reliability, data integrity, and regulatory compliance.

Key Responsibilities

Lead the implementation and maintenance of laboratory automation and computerized systems.

Support laboratory platforms ranging from standalone instruments to global systems integrated with LIMS.

Ensure compliance with GMP, Data Integrity requirements and 21 CFR Part 11 regulations.

Develop and maintain technical and administrative procedures, including backup and recovery strategies.

Investigate laboratory and quality-related non-conformances.

Perform root cause analysis using methodologies such as 5 Whys, Fishbone and KT Analysis.

Define and implement CAPAs and effectiveness checks.

Act as SME during audits and regulatory inspections.

Support continuous improvement and laboratory digitalisation initiatives.

Requirements

Bachelor's degree in Life Sciences, Computer Science, Engineering or a related field.

Minimum 2 years of experience in a GMP-regulated pharmaceutical environment.

Experience with laboratory automation, computerized systems, or Computerized System Validation (CSV).

Good understanding of GMP, FDA and EMA regulatory requirements.

Strong analytical and problem-solving capabilities.

Programming or software development experience is highly desirable.

Fluent English communication skills.

Preferred Experience

Empower

SoftMax Pro

SDMS

LIMS

TrackWise

32Karat

TECAN robotics

GAMP5

Lean Six Sigma

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