Gmp Systems Operating Engineer

Turgut İlaçları A.Ş.

Qualifications

Minimum of B.Sc. degree with a major in a four year mechanical engineering program

Minimum 2 years of experience at a pharmaceutical company in a similar position

Preferably participated in a GMP, product inspection by the MoH and preferable by foreign authorities such as EMA or FDA

Writing and release of URS for an engineering plant in the GMP area, supervision and release of DQ, FAT, SAT, IQ, OQ, PQ (if applies) and end user trainings from the suppliers of Clean Utility Systems such as pharma water systems (PW, WFI, PS), HVAC systems, BMS/EMS systems, Class 0 compressed air systems, medical gas systems etc.

Good experience (min. 2 years) in operation of Clean Utility Systems such as pharma water systems (PW, WFI, PS), HVAC systems, BMS/EMS systems, Class 0 compressed air systems, medical gas systems etc.

Carried out annual periodic maintenance, spare parts replacement and troubleshooting of Clean Utility Systems such as pharma water systems (PW, WFI, PS), HVAC systems, BMS/EMS systems, Class 0 compressed air systems, medical gas systems etc.

Preferably experience with production plants such as aseptic/ sterile solutions, IV/ IM solutions, PD/TPN/HSF solutions or at a Biopharmaceutical Drug Substance, Drug Product Production Facility for minimum 2 years

Good command of written & verbal English

Excellent command of MS Office programs

Strong analysis and reasoning skills, ability to empathize and persuade

Competent in communication, setting priority, time and project management, ability to manage multiple tasks

Ability to manage operations synchronously with Engineering and Technical Services Manager, Qualification and Calibration Engineers and / or Technicians, Quality Assurance Manager and / or Engineers

Preferably resident in the Anatolian side of İstanbul or Kocaeli

Job Description

·        Working as a GMP Systems Operating Engineer at Turgut Pharmaceuticals Inc Gebze Biopharmaceutical Drug Substance, Drug Product Production Facility under the Engineering and Technical Services Directorate

·        Writing and release of URS for an engineering plant in the GMP area, supervision and release of DQ, FAT, SAT, IQ, OQ, PQ (if applies) and end user trainings from the suppliers of Clean Utility Systems such as pharma water systems (PW, WFI, PS), HVAC systems, BMS/EMS systems, Class 0 compressed air systems, medical gas systems etc.

·        Being responsible of the operation of Clean Utility Systems as described above.

·        Managing and supervising the application of operations such as spare parts replacement, chemical addition, annual services, revalidations, recalibration, system software, performing daily checks, filling and reporting 'Daily Failure and Control Forms' of the systems described above.

·        Keep continuous the necessary compliance status, especially for inspections of local and international health authorities and be the responsible spokesperson for the inspectors for the above mentioned technical plants.

·        Assist the QA (Quality Assurance) Department in the preparation of Engineering Documents, and ensure the sustainability of Engineering Documents of Clean Utility Systems which are mentioned above.