Name: Validation Engineer and Metrology
Price: 650 EUR
Availability: InStock

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Languages

French
Native or bilingual
English
Fluent
Italian
Conversational

Workplace preferences

Can work on-site

Lille (up to 50km)

LFB
Commissioning and Qualification Consultant Fill & Finish
March 2024 - Today (2 years and 3 months)
Arras, France
Qualification of Fill & Finish equipment (Isolators, filling line, Autoclaves, Washers…)
Drafting, updating qualification/validation plans (VP, MVP)
Drafting, updating qualification protocols and reports (DQ, FAT/SAT, IQ, OQ, PQ)
Drafting, updating traceability matrices (TM) and data review (DR)
Planning, organizing, and executing qualification tests (DQ, FAT, SAT, IQ, OQ, PQ)
Coordinating internal and external service providers involved in initial qualifications
Managing and drafting deviations according to the system in place during qualifications
Ensuring the maintenance of service performance indicators
Optimizing existing qualification processes, with a focus on efficiency and cost reduction
LFB - C&Q HVAC
Commissioning and Qualification Consultant HVAC
January 2022 - January 2022
Arras, France
Qualification of cleanrooms « HVAC, Clean Air Units, Floors, Partitions... »
Qualification of storage areas and cold rooms
Implementation of the qualification strategy "PDV, URS, ITP..."
Drafting of protocols and reports (QC, FAT, SAT, IQ, OQ, and PQ)
Performing risk analyses and criticality analyses.
Organization and management of qualification tests
Managing non-conformities and change requests
Les laboratoires TERIAK
Qualification and Metrology Manager TUNIS
July 2021 - March 2022 (8 months)
Tunis, Tunisia
Qualification of cleanrooms « HVAC, Clean Air Units… »
Qualification of machines « FAT, SAT, IQ, OQ, and PQ » (Dry form, liquid, sterile, and injectable)
Cleaning validation
Drafting of qualification documents
Management and monitoring of non-conformities
Validation of steam sterilization processes (autoclave…)
Metrological controls of equipment Risk/impact analysis,
Active participation in internal and external audits, ensuring compliance and continuous process improvement.