Training Specialist

Flexsis AG, IT-GITR

Flexsis AG, IT-GITR

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  • Veröffentlicht:

    03 April 2024

  • Pensum:

    100%

  • Vertrag:

    Festanstellung

  • Arbeitsort:

    2543 / Lengnau
INTRODUCTION
For our client, the Thermo Fisher Scientific Inc., a world leader in serving science based in Lengnau, we are looking for a committed personality as
Training Specialist
This is a full-time and permanent position. The start date is as soon as possible or within the notice period.
ASSIGNMENT DESCRIPTION
As a Training Specialist (Operations) you lead our trainings in operations. This position deputies first line contact for solving to support an area of expertise in Drug Substance Manufacturing (eg. USP, DSP, single use, solution preparation and support).
You represent operations for facility fit out, tech transfer, commissioning, qualification and validation of new production lines or processes. Participates in Technology Transfer of new products. Supports CVQ, PQ, Process Validation execution.
Your responsibilities:
  • Acts as training owner within operations
  • Owns training and onboarding concepts in manufacturing such as defining the curriculum, on-the-job training, maintaining a list and mentoring the trainer, defends the training concept to the authorities
  • Ensures technical support of critical process activities, collaborating closely with other departments, particularly MSAT. Raises and owns training related manufacturing deviations.
  • Represents DS Manufacturing department in multi-functional teams and externally (customer and authorities), including tech transfer.
  • Supports the design and purchasing of production equipment and automation systems in accordance with process requirements and in compliance with applicable cGMP requirements.
  • Supports the commissioning and qualification, development and validation execution for the production process.
  • Lead and develop Manufacturing Excellence in order to run robustly and efficiently.
  • Build multi-functional connections and work well with other support functions such as Quality Assurance, Quality Control, Manufacturing, Engineering, Validation, and other relevant functional areas
REQUIRED PROFILE
  • Bachelor/Master in Chemistry/Biochemistry/ Biotechnology/Biology/Food Science
  • >10 years successful experience in pharmaceuticals operations in a GMP relevant environment.
  • Experience in biotech processes, additionally sterile processes or single use equipment handling or CIP/SIP processes.
  • Fluently in German and English (speak and written)
  • On-call duties is expected
  • Willingness to travel up to 15%
  • Experience in matrix environment
  • A first experience in automated technology is a significant advantage
Application process
Interested? You can find more information here:

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  • Flexsis AG, IT-GITR

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