Job Title: GMP Technical Services Engineer
At Philogen S.P.A., a leader in the development of innovative anti-tumor therapies, we are seeking a highly motivated and qualified individual to fill this critical role.
Key Responsibilities:
* Schedule and monitor maintenance and calibration activities, ensuring compliance with regulatory requirements.
* 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 adherence to Good Manufacturing Practices (GMP) regulations.
* Identify and resolve process problems, implementing continuous improvements.
* Provide technical support during regulatory inspections.
Ideal Candidate:
* Masters 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 regulations and qualification and validation guidelines.
* Able to work effectively in a team and manage projects independently.
* Excellent communication and problem-solving skills.
* Professional proficiency in English language.
What We Offer:
* Challenging and innovative working environment.
* Opportunities for professional growth and continuous training.
* Competitive salary package and company benefits.