GMP Technical Services Engineer

3 settimane fa

Siena, Toscana, Italia Philogen S.p.A. A tempo pieno

Philogen S.p.A., a biotech company listed on the Milan Stock Exchange and a leader in the development of innovative anti-tumor therapies, is looking for a highly motivated and qualified "GMP Technical Services Engineer" .

In particular the successful candidate will be responsible to:

  • Support the maintenance department, scheduling and monitoring the maintenance and calibration activities and managing the contractors or suppliers for these activities.
  • Plan and conduct qualification and validation activities for utilitiesequipment and processes;
  • Draft and review technical documentation, including qualification and validation protocols and reports;
  • Collaborate with cross-functional teams to ensure compliance with Good Manufacturing Practices (GMP) regulations;
  • Identify and solve process problems, implementing continuous improvements;
  • Provide technical support during regulatory inspections.

The ideal candidate should have:

  • Master's Degree in Chemical Engineering or related discipline;
  • Minimum 3 years' experience in a similar role in the Biotech or pharmaceutical industry;
  • Thorough knowledge of cGMP (EMA and FDA requirements) regulations and qualification and validation guidelines;
  • Ability to work in a team and manage projects independently;
  • Excellent communication and problem solving skills;
  • Professional knowledge of english language.

We offer:

  • Challenging and innovative working environment.
  • Opportunities for professional growth and continuous training.
  • Competitive salary package and company benefits.

Job location :

Siena

We invite interested candidates to submit their applications expressly authorizing the processing of personal data in accordance with Legislative Decree 196/2003. Our recruitment adheres to the provisions of Legislative Decree 198/2006, and we welcome applications from candidates of any gender orientation or expression, sexual orientation, age, ethnicity, or religious belief.

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