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