Senior Validation Manager

hace 4 semanas


Alcobendas, Madrid, España Cytiva A tiempo completo
Job Summary

Cytiva is seeking a highly skilled Senior Validation Manager to lead paid service customer-specific technical projects. This role will work directly with external Biotech customers and internal commercial teams to define, implement, and complete customer-specific technical projects.

The ideal candidate will have a strong background in Microbiology and Chemistry Validation testing, with experience in Filter/Filtration concepts and advanced laboratory techniques. They will be responsible for generating specific test protocols and reports to support customer requests and assigned responsibility for intermediate to complex projects.

This is a remote work opportunity with 10% travel, overnight. The successful candidate will be fluent in English and have a valid driver's license with an acceptable driving record.

Key Responsibilities
  • Lead, delegate, 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 action required to meet required target dates.
  • Schedule work into the laboratory in conjunction with the laboratory team leaders to 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, Master's 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 apply GLP as appropriate, familiar with GMP requirements.
  • Fluent in English (reading and writing).

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