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Lächelnde Mitarbeiterin im Gespräch mit Kollegin im Büro
Lächelnde Mitarbeiterin im Gespräch mit Kollegin im Büro
ID: 752000

Engineer for Packaging Lines and Processes

  • Pharma & Biotech
  • Asap
  • Packaging Qualification/Validation, FMEA, GMP
  • K-Recruiting GmbH
Ansprechpartner:

Julius Strack

+49 89 1890998-614

julius.strack@k-recruiting.com

Overview

Availability
Asap, 5 days/week, on-site & remote
Qualification
Engineering/Packaging, Diploma
Language Skills
German (native), English (business fluent)
Relevant Expertise
Qualification Engineer for Packaging Lines, Process Engineer, Packaging Qualification/Validation , validation of packaging process, Packaging specifications, FMEA, Risk Analysis, Feasibility, primary, secondary and tertiary packaging, GMP, Pharma & MedTech

Key-Facts

  • Expert for the qualification & validation within the packaging process and for the relevant documentation and requirements

  • Experience within the pharmaceutical and medical industry, therefore well aware of GMP/GDP standards and the MDR norm

  • Has been placed by K-Recruiting multiple times and has always received excellent feedback

Extract from previous activities

2021 – date

Pharmaceutical Company, Germany (via K-Recruiting)

Packaging Validation Engineer

  • Documentation and release for packaging production lines

  • Qualification of packaging line

  • Conducting of documentation, URS, FMEA, FAT, DQ, IQ, OQ, PQ, SOPs

  • Validation of packaging processes

  • Qualification of inspection lines for pharmaceutical products

2019 – 2020

MedTech Company, Switzerland (via K-Recruiting)

Packaging Consultant

  • QA Compliance Engineering for medical devices industry

  • Qualification of packaging lines

  • Conducting of documentation for packaging line (e.g. SOPs, WI, URS, QNA, FMEA, SAT, FAT, DQ, IQ, OQ, PQ)

  • Validation processes (FMEA, Risk analysis for feasibility, transport validation)

  • Auditing of suppliers for packaging lines and production materials

2019

Biotechnological Company, Germany (via K-Recruiting)

Packaging Consultant

  • Validation of packaging lines / processes for primary, secondary and tertiary packaging

  • Implementation /auditing of suppliers for packaging lines and production materials

  • Leading of development projects (syringes, foils, blisters, boxes)

2019

Pharmaceutical Company, Germany

Packaging Validation Manager

  • Specification for production packaging, sterilization and cleaning processes

  • Support and review of documentation

  • Conducting of transport validation tests, statistics, documentation

2018

MedTech Company, Germany

Packaging Validation Consultant

  • Track and Trace Process, Auditing, Self inspection internal standards

  • Validation of production processes (packaging process / GDP transport validation)

2016 – 2017

Pharmaceutical Company, Germany

QA Compliance Engineer

  • Conducting of documentation, CAPA, URS, QNA, FMEA, SAT, FAT, DQ, IQ, OQ, PQ

  • Validation of pharmaceutical processes (Risk analysis for feasibility, Qualification of Packaging lines, HAVC, AP, Pharma packaging process / GDP Transport validation)