Maja Smilevska

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Senior Process / Validation Engineer (C&Q)

Ref #: ID: 32085
Maja Smilevska 07/12/2021
Location: Karlsruhe, Germany, Switzerland Not Disclosed Karlsruhe, Germany, Switzerland
Salary: 80,000++ £
OTE: TBC
Type: Permanent
Seniority: Mid/Senior Level
Date: 07/12/2021
Senior Process / Validation Engineer (C&Q)

As Process / Validation Engineer C&Q (Commissioning & Qualification) for our client, you are responsible for installation, configuration, verification, and validation of pharmaceutical equipment at the customer’s site.
The focus will be on qualification and validation of inspection and packaging machines.

While our offices are located in Karlsruhe, we support working from remote / from home!

Your role within the team

  • You support our well-known pharmaceutical customers with design and execution of their qualification (and validation) activities in a regulated industry
  • You are responsible for qualification and validation activities from planning to specification to acceptance of a machine
  • You coordinate configuration and verification activities in customer projects and ensure successful execution
  • You create risk analysis and verification strategies
  • You are responsible for machine-specific documentation following regulatory needs of the pharmaceutical industry to achieve compliance

Your profile

  • You have an engineering degree or equivalent qualification as master / technician (f/m/d)
  • You come with multi-year project engineering expertise (pharmaceutical or process industry preferred)
  • You are an expert in qualification and validation in the pharmaceutical domain
  • You know the requirements, regulations, and guidelines of the pharmaceutical industry (FDA, EU, ICH, …), GAMP 5 best practices, ASTM E25000 standard, and understand pharmaceutical production processes
  • You are a team player with good communication skills and know how to manage your projects and your schedule
  • You excel at distinct analytical and conceptional competencies
  • You are experienced in dealing with international customers
  • You are willing to travel
  • German language skills are a plus
  • Specific domain knowledge (e.g. lyophilization or aseptic processing) is 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 mulitnational Group
  • Attractive and performance-related compensation
  • At the Karlsruhe location: in-house child care, fitness studio, cafeteria
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