Person-in-the-Plant

Tunnell Consulting

Person-in-the-Plant

Tunnell Consulting

Berlin, Germany

Responsibilities:

Support the tech transfer of a bulk vaccine drug substance manufacturing process to a Contract Manufacturing Organization by operating as a "man-in-the-plant".

The support will take several forms:

  • Equipment and utilities qualification (IQ/OQ);
  • Process qualification (PQ) designing and conducting engineering runs and preparing for validation;
  • Process and cleaning validation preparing the validation plans, protocols, sampling plans, overseeing their execution and writing the reports, addressing potential deviations;
  • Quality Assurance to support IQ/OQ/PQ, validation and the review and sign-off of key documents such as batch records, production SOPS…

Requirements:

Education:

  • Bachelor's degree in sciences or engineering (chemical engineering, biochemical engineering, mechanical engineering, electrical engineering or molecular biology, biology, microbiology).

Experience:

  • Solid vaccine/biotech manufacturing operations experience in a cGMP setting (5 to 10 years or more depending on the role;
  • Must have experience in manufacturing operations, or technology, or QA of commercial biotech/biologics/vaccine upstream processes (Bulk Drug Substance). It is critical to have a solid understanding of cGMP.

Ideally the resource will be fluent in both English and German. English only may be acceptable.

The location is 2 hours by car South West of Berlin. Resources based in Germany are preferred but resources in Western Europe in general are acceptable.

Start Date: late September or early October
End Date: 9 months

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© EuroJobsites 2019

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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