Packaging Engineer with over 25 years of experience gained mainly in multiple positions and freelance project within the medical devices and pharmaceutical industry
Expert in the design but also the qualification and validation of primary/secondary/tertiary packaging and packaging machines
Aware of industry standards and regulations as well as packaging norms (e.g. MDR, GMP, ISO 11607, etc.)
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Our content and services may vary by location.
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Overview
- Availability
- Asap, full-time, onsite & remote
- Qualification
- Engineering/Packaging, Diploma
- Language Skills
- German (native), English (business fluent), French (advanced)
- Relevant Expertise
- Packaging Expert, Qualification/Validation of Packaging Processes, Primary/Secondary/Tertiary Packaging, Packaging Development, Packaging Design, DQ/IQ/OQ/PQ, Audits, GMP, MDR, ISO 11607, Medical Devices & Pharma
Key-Facts
Extract from previous activities
Medical Devices Company, Switzerland
Packaging Expert
Validate packaging testing & packaging performance
Packaging development for medical device materials
Supporting EU-MDR Compliance readiness
MDR documentation & ISO 11607
Pharmaceutical Company, Germany
Packaging Validation Manager
Documented & released packaging production lines
Conducting documentation, URS, FMEA, FAT, DQ, IQ, OQ, PQ, SOPs, WI
Validated pharma packaging processes
Qualify inspection lines for pharmaceutical devices
TOP 5 Medical Devices Company, Germany
Packaging Expert
Packaging validation of medical devices; ISO 11607
Blister packaging transport & performance validation
Track and Trace Process, Auditing, Self-inspection intern standards
Validation of production processes (packaging process / GDP transport validation)
Pharmaceutical Company, Germany
Packaging Engineer
Technical Consultant for Packaging processes
Leading development projects (syringes, foils, blisters, boxes)
Validation of packaging lines / processes for primary, secondary, and tertiary packaging
Implementation /auditing of suppliers for packaging lines and production materials
Packaging solutions & Project management
Strategic control of packaging production
Establish a packaging supplier network
Process control & optimization
Compliance Management (Labelling, Packaging)
Medical Devices Company, Germany
Packaging Project Manager
Coordination of activities of all involved departments
Prepare project guidelines and financial estimates
Tracking project timelines and coordinating stakeholders interests
Validating blister packaging concepts and production processes (packaging/GDP transport validation)
Medical Devices Company, Germany
Packaging Consultant
Conducting of documentation, CAPA, URS, QNA, FMEA, SAT, FAT, DQ, IQ, OQ, P
Packaging development for Medical and Pharmaceutical Products
Packaging/Labelling: Sterile Products
Revalidation of packaging concepts, conduction of testing: ASTM D4169, D4728, D5276
Supporting FDA readiness projects
Transport Validation of Blister Packaging Systems
Big Medical Devices Company, Germany
Consultant Packaging Validation Engineer
Packaging Validation (Sterile Medical Devices); ISO 11607
Packaging Development & Performance Validation
Supporting Purchasing Department with packaging
Supporting FDA remediation projects: Specifications for secondary and tertiary packaging
Review of documentation, CAPA, URS, QNA, FMEA, GMP
Assisting with FDA readiness for medical products
Conducting of transport validation tests, statistics, documentation