gmp technical services engineer
3 settimane fa
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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