Coordonnateur Validation - Validation Coordinator (Temporaire, 12 mois)
Core
Coordinate and execute validation activities for cleaning processes and manufacturing processes in a regulated liquid/solid/semi-solid health product manufacturing environment to ensure product quality and prevent cross-contamination.
Role type
Validation Coordinator (GMP)
Builds
Validated cleaning and manufacturing processes for consumer health products
Domain
Pharmaceutical/Healthcare Manufacturing (GMP)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, cleaning validation protocols, sampling techniques (swab/rinse), limit of detection (MACO) calculations, process performance qualification (PPQ), continuous process verification (CPV), risk assessment, regulatory documentation, cross-functional coordination
Preferred skills
English fluency, practical cleaning validation execution experience, PPQ support experience, data collection for CPV
Technologies
HPLC, TOC analyzers, CIP systems, LIMS (implied via lab submissions)
Responsibilities
Execute cleaning validation protocols and verification plans aligned with lifecycle principles; perform and coordinate swab/rinse sampling, sample handling, chain-of-custody, and lab submissions; execute hold time studies and evaluate campaign limits; support PPQ plans and continuous process verification (CPV) setup; lead or contribute to cleaning/validation deviations; write, execute, and close validation protocols and risk assessments; update controlled documents (SOPs/WIs) to align with validated state; coordinate with Production, Engineering, CQ, AQ, and EHS for equipment and lab readiness; prepare for audits and act as SME during inspections.
Seniority
Mid-level, hands-on IC
