Gmp Technical Services Engineer

3 settimane fa

Siena, Italia Philogen A tempo pieno

Job Title: GMP TECHNICAL SERVICES ENGINEER
Department: Others, QA
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 utilities, equipment, 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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