CSV QC Engineer - LIMS & GMP Validation

Akkodis; Waver; Sur place; EUR 48 000 - 72 000; Plein temps

Avantages offerts par ce poste

Buddy program

Career development

Permanent contract

International group environment

Company events calendar

Résumé du poste

Akkodis is seeking a CSV Engineer in Belgium to support the Computerized System Validation of QC laboratory systems within a GxP-regulated environment. You will validate and qualify systems and equipment such as LIMS and CDS, and prepare/execute validation documents per approved protocols.

You will ensure GMP/GxP compliance, data integrity, and collaborate with Quality, IT and vendors while managing deviations and risk assessments throughout the lifecycle of validated QC systems.

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Computer Science, Automation or related field.
• Knowledge of cGMP and/or GLP expectations.
• Advanced written and verbal communication skills.
• French fluent; English is a plus.
• Ability to handle pressure situations.
• Organized, proactive, solution-oriented, open-minded and flexible.
• Enjoy meeting people, presenting results and advising customers.

Responsabilités

• Support the Computerized System Validation (CSV) of QC laboratory systems in a GxP environment.
• Validate and qualify laboratory computerized systems and equipment (e.g., LIMS, CDS, analytical instruments).
• Prepare and review URS, Functional Specifications, Risk Assessments, Validation Plans, IQ/OQ/PQ protocols and Validation Reports.
• Execute and document validation and qualification tests per approved protocols.
• Ensure GMP/GxP compliance (FDA 21 CFR Part 11, EU GMP Annex 11) and Data Integrity/ALCOA+ principles.
• Support validation of analytical instruments and laboratory equipment used by QC teams.
• Manage deviations, CAPAs, Change Controls and incidents related to validated QC systems.
• Perform risk assessments and impact assessments for computerized systems and equipment.
• Participate in periodic reviews to maintain validated state throughout lifecycle.
• Collaborate with Quality Control, Quality Assurance, IT, Engineering and external vendors.
• Ensure documentation, traceability and data integrity of QC systems.

Connaissances

CSV engineering

GxP knowledge

Communication skills

French fluency

English knowledge

Formation

Bachelor’s or Master’s degree in Life Sciences / CS / Automation

Outils

LIMS

CDS

Description du poste

Akkodis is seeking a CSV Engineer in Belgium to support the Computerized System Validation of QC laboratory systems within a GxP-regulated environment. You will validate and qualify systems and equipment such as LIMS and CDS, and prepare/execute validation documents per approved protocols.

You will ensure GMP/GxP compliance, data integrity, and collaborate with Quality, IT and vendors while managing deviations and risk assessments throughout the lifecycle of validated QC systems.