Commissioning and Qualification Expert

4 days ago


Arvada, Colorado, United States Sapphire Solutions Full time

Job Title: Senior CQV Engineer

Location: Hamburg Area, Germany

Job Type: Contract / Freelance (6 months+)

Key Responsibilities:

  • Assist in the setup, operation, and maintenance of new facilities and laboratory equipment, focusing on qualification and technical aspects.
  • Lead technical projects, modifications, and improvements of facilities, including change control.
  • Initiate and execute change control procedures and qualification activities.
  • Create and execute qualification documents in accordance with norms and standards.
  • Engage in technical discussions with equipment suppliers.
  • Prepare for inspections and provide support for qualification assignments.
  • Ensure high availability of facilities and equipment.
  • Drive process improvements and standardizations.
  • Maintain and qualify measuring and testing instruments.
  • Execute GMP-compliant requalification activities.
  • Collaborate with project teams, particularly Construction Management.

Requirements:

  • Bachelor's degree in engineering with a focus on process engineering, mechanical engineering, or a related natural or engineering science field.
  • Several years of professional experience in the pharmaceutical industry.


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