QC Lab Automation Specialist: GMP Systems & CSV | Hybrid

Progressive

Randstad

Hybrid

EUR 65,000 - 90,000

Full time

6 hours ago

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Job summary

Johnson & Johnson in Leiden (Hybrid) seeks an experienced NC Automation Specialist to join the Quality Control organization, working 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 organization, working with laboratory,

Qualifications

Bachelor’s degree in Life Sciences, Computer Science, Engineering or related field.
Minimum 2 years in GMP-regulated pharmaceutical environment.
Experience with laboratory automation, computerized systems, or CSV.

Responsibilities

Lead the implementation and maintenance of laboratory automation and computerized systems.
Support platforms from standalone instruments to global systems integrated with LIMS.
Ensure GMP, data integrity, and 21 CFR Part 11 compliance.
Develop and maintain procedures, including backup and recovery strategies.
Investigate quality and lab non-conformances.
Perform root cause analysis using 5 Whys, Fishbone, and KT analysis.
Define and implement CAPAs and effectiveness checks.
Act as SME during audits and inspections.
Support continuous improvement and lab digitisation initiatives.