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Validation Manager Biotherapeutics DE/EN

  • Job type: Permanent
  • Location: Switzerland
  • Salary: Negotiable
  • Job reference: 333633/004_1539331330
  • Sector: Quality Assurance, EPM Scientific
  • Date posted: 12/10/2018

Validation Manager - Biotherapeutics DE/EN

Location: Deutschschweiz

Overview:

A multinational biotech company that produces biotherapeutics for rare diseases is seeking a Validation Manager to lead their manufacturing and cleaning processes.

They are looking for an experienced leader with a technical validation background in pharmaceutical/biotech manufacturing to oversee the activities of three scientific groups (20-25 people).

Responsibilities:

  • Oversee the operations of a team of approximately 20 employees including scientists and team leads. Including developing plans for personal and technical development.

  • Establish and ensure the sustainability of a cGMP compliant system for cross-functional manufacturing and cleaning processes.

  • Create and review validation documentation, including setting up a sustainable validation master plan and related reporting (i.e. SOPs, risk analysis documents).

  • Manage technical reviews of processes and validation for stability studies for products.

  • Direct and oversee the execution of validation projects including deviation management, investigations, and change management.

  • Present validation procedures and results at inspections.

Requirements:

  • Must have leadership experience in a pharmaceutical / biotechnology setting.

  • Degree-educated in a relevant discipline (i.e. chemistry, biochemistry) with industry experience in complex biological processes.

  • Advanced knowledge of cGMP regulations, validation, and process engineering.

  • Sound analytical thinker and problem solver with the ability to clearly articulate solutions and delegate effectively.

  • Capable of working across hierarchical levels in a cross-functional environment.

  • Must be Fluent in both German and English.

Want to know more? Feel free to contact EPM Scientific Zurich (see contact details). I would be happy to explain more details about the role and answer any questions you may have.

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