Automation Validation Specialist – QC Labs (GMP/CSV)
Panda International
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Job summary
Panda International is seeking an experienced Automation Specialist to support QC laboratories in a pharmaceutical setting in Leiden. You will oversee laboratory automation, computerized systems, data integrity and GMP compliance, acting as SME for installation, validation and maintenance of systems such as LIMS, Empower, and TrackWise.
The role involves leading non-conformances, CAPAs and audits, troubleshooting, and collaborating with global teams to drive continuous improvement and LEAN
Qualifications
- Bachelor's degree required in Life Sciences, CS, or related field.
- Minimum 2 years pharma GMP/automation experience.
- Hands-on software development experience.
- CSV validation in a GxP environment.
- Knowledge of Empower, SoftMax Pro, LIMS or TrackWise is a plus.
- Understanding GMP and FDA/EMA guidelines is required.
Responsibilities
- Lead laboratory system implementations from instruments to LIMS.
- Develop and maintain installation, admin and maintenance procedures.
- Ensure data integrity and backup/disaster recovery planning.
- Provide troubleshooting for computerized systems and automation.
- Ensure compliance with GMP and 21 CFR Part 11.
- Collaborate with cross-functional global teams on projects.
- Lead investigations into non-conformances and perform CAPAs.
- Support internal audits and inspections.
- Drive continuous improvement and LEAN initiatives in lab processes.
Skills
Education
Tools
Job description
Panda International is seeking an experienced Automation Specialist to support QC laboratories in a pharmaceutical setting in Leiden. You will oversee laboratory automation, computerized systems, data integrity and GMP compliance, acting as SME for installation, validation and maintenance of systems such as LIMS, Empower, and TrackWise.
The role involves leading non-conformances, CAPAs and audits, troubleshooting, and collaborating with global teams to drive continuous improvement and LEAN
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