Senior Validation Manager

hace 5 días

Madrid, Madrid, España Cytiva A tiempo completo

About the Role:

Cytiva is seeking a highly skilled Senior Validation Manager to lead paid service customer-specific technical projects. As a key member of our team, you will work directly with external Biotech customers and internal commercial teams to define, implement, and complete customer-specific technical projects.

Key Responsibilities:

  • Lead and review projects of intermediate to complex complexity with no guidance and direction.
  • Co-Lead or Lead Technical consultation with customers (internal and external), involving validation testing plans and data review, test recommendations based on regulatory knowledge and expectations, leveraging SMEs.
  • Lead team collaboration and communication with the lab team to ensure all test requirements are in place.
  • Travel to customer sites for technical meetings and co-lead or lead customer trainings/presentations, using SMEs.
  • Establish project priorities and decide appropriate actions required to meet target dates.
  • Schedule work into the laboratory in conjunction with the laboratory team leaders.
  • Ensure all projects meet or exceed on-time delivery expectations by the team.
  • Update management on the status of assigned projects, including completion, delays, or problems – lead development and implementation of countermeasures.

Requirements:

  • Bachelor's, Masters Degree, or PhD in Science or Life Science.
  • Long-standing years of working experience in the biotech industry.
  • Background in Microbiology and Chemistry Validation testing with an understanding of Filter/Filtration concepts.
  • Skilled in advanced laboratory techniques and measurement methods.
  • Ability to perform complex test work and application of GLP as appropriate, familiar with GMP requirements.
  • Fluent in English (reading and writing).

Travel, Motor Vehicle Record & Physical/Environment Requirements:

  • Ability to travel – 10% travel, overnight.
  • Must have a valid driver's license with an acceptable driving record.

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