Qualifier (male/female/diverse) - Aspinwall, PA, United States - Cascade Enterprises

James Miller

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James Miller

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Freelance
Description
We are a manufacturer of thermoforming packaging machines and special machines for the medical, pharmaceutical, and food industries. Our machines are used worldwide.

To strengthen our team, we are currently looking for a:


Qualifier (m/f/d)

Your responsibilities:

  • Creation, review, and approval of risk analyses / FMEAs (based on GMP), design documents (FDS, HDS, SDS), and test documents (DQ, IQ, OQ)
  • Conducting planned qualification tests at our facility in Weißensberg and at customer sites
  • Conducting internal training on qualificationrelated topics
  • Supporting the project team in all questions related to GMPcompliant processes
  • Responsibility for deviation management, tracking, and monitoring
  • Collaboration across departments and areas

Your profile:

  • Completed degree in pharmaceutical or medical technology with a good understanding of technical documents (drawings, schematics, technical documentation) or a career changer with a degree in mechanical engineering or a comparable qualification
  • Excellent knowledge of MS Word
  • Good computer skills
  • Very good German and English skills, additional language skills are advantageous
  • Willingness to travel (internationally)

We offer:

  • A modern workplace with a permanent position
  • A responsible and diverse job that allows for hybrid work
  • Thorough training
  • An open and collegial team
  • Flexible working hours
  • Performancebased compensation with benefits (vacation pay, profit sharing, offers

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