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Tech Services Technician Noáin Spain,  

3pbio (company)


Posted on : 21 September 2017

Project Description

Primary Objective of the position:

  • Responsible of the execution of the Tech Transfer Policies of the department according to the in-force SOP s.
  • Responsible of the execution of the Purchasing and Introduction of new equipment according to the in-force SOP s.
  • Responsible of the execution of the Validation activities in agreement with the in-force SOP s.

Main responsibilities:

  • Prepare and execute the protocols corresponding to the Tech Transfer policies in a Biotech industry, not only from customer to facility but also among departments.
  • Evaluate the technical documentation of the potential processes to be transferred (Process and analytics).
  • Prepare and execute Cleaning, Process and Analytical Validation Protocols.
  • Coordinate the execution of the Validation Campaigns.
  • Lead the risk analysis sessions following HAZOP/FMEA methodologies.
  • Prepare URS s of the equipment needed for the execution of a certain project as well as the internal documentation for the right management of the equipment.
  • Follow-up the Tech Transfer runs and Scale-Up batches in order to assure the right performance of these batches. Prepare the Tech Transfer report.
  • Comply and assure the compliance of the GMP regulations.

Assessment criteria:

  • 5 years of experience in tech transfer activities of Biological processes, internal and external tech transfer.
  • 2 years of experience in the management of new equipment, from the purchase need to the installation and set-up in the place of work.
  • At least 5 years of experience in process validation and cleaning validation activities, desirable in a biotech company.
  • Experience in risk analysis and HAZOP/FMEA methodologies.
  • Expert in GMP regulations.

Other requirements:

  • Fluent in English.
  • Ability to effectively work within a team and as a leader.

We offer:

  • Immediate incorporation in a young and motivated working environment, in a company in full expansion.
  • Attractive remuneration according to experience.

Contact Email: recruitment@3pbio.com

 

 

 

Locations

31110 Noáin Navarra, Spain

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