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Senior CQV Engineer (m/f/d)

Posting Date:  Sep 23, 2022
Location: 

Karlsruhe, DE

Business Area:  Pharma
Company:  Körber Pharma Consulting GmbH

Senior CQV Engineer (m/f/d)

Your role in our team

 

  • You are responsible for CQV activities from planning to specification to acceptance of a machine
  • You support our well-known pharmaceutical customers with design and execution of their qualification (and validation) activities in a regulated industry
  • You lead and train junior team members
  • You are responsible for machine-specific documentation (URS, designs, risk analysis, test plans etc.) and verification strategies following needs of the regulated industry to achieve quality and compliance
  • You perform or support project management activities
  • You support the customer with the required range of SOPs and provide the required guidance.

 

Your profile

 

  • You have an engineering degree or equivalent qualification as master / technician (f/m/d)
  • You know the requirements, regulations, guidelines, cGMPs, and best practices of the pharmaceutical and biotech industry (FDA, EU, ICH, ASTM E2500, GAMP 5, …)
  • You come with multi-year project engineering expertise (pharmaceutical or biotech industry preferred)
  • You are a team player with good communication, time management, and problem-solving skills
  • You have a demonstrated ability to interact effectively with all levels of an organization
  • You are willing to travel regionally and internationally
  • Your come with basic understanding of documentation that supports PCS (e.g. P&ID’s, electrical drawings, certificates of conformance, pneumatic drawings, etc.)
  • Domain knowledge or experience with packaging and inspection machines, filling machines, lyophilization, super-ordinated systems (e.g., ERP, MES, DCS, historian), and items related to WFI, HVAC, cleanrooms, utilities etc. is a plus
  • German language skills are a plus

 

Your benefits

 

  • Unlimited contracts and flexible working arrangements
  • An innovative job in a national and international environment
  • Exciting challenges and a long-term perspective for personal development in a growing team
  • A state-of-the-art working environment in a highly motivated and professional team
  • Flat hierarchies and a considerate and friendly working atmosphere
  • Very interesting insights into the business world at a variety of our customers
  • Many exciting career opportunities for the future within the Körber Group
  • Attractive and performance-related compensation
  • At the Karlsruhe location: in-house childcare, fitness studio, cafeteria

 


Recruitment Team

For questions please contact us via jobs@koerber.com.
Please apply exclusively via the “Apply now” button.


Recruitment-Team
For questions please contact us via jobs@koerber.com.
Please apply exclusively via the “Apply now” button.

Körber Pharma is a Business Area of Körber, an international technology group with around 10,000 employees and more than 100 locations worldwide. At Business Area Pharma we offer a unique portfolio of integrated solutions that deliver the difference along the pharma value chain. Spanning our in-depth expertise in consulting, inspection, handling, packaging machines and materials, track & trace and software, Körber has always the right solutions to unlock the potential of our customer’s productivity. With proven understanding of pharma process and regulation challenges, Körber is the partner to make the most out of pharma and biotech production for customers.


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