Microbiology Environmental Sterile Unit Head

About Minapharm:

Minapharm Pharmaceuticals is a leading pharmaceutical company in Egypt and the Middle East and the largest end-to-end manufacturer of biological therapies in MEA with over 20 years of experience in cellular and bioprocess engineering. Headquartered in Cairo, Minapharm commercializes over 100 life-saving and life-enhancing products ranging from small molecules to complex bioengineered proteins and viral vectors, with an impressive immunotherapy pipeline. Together with its wholly-owned Berlin-based subsidiary, ProBioGen AG - a world-leading CDMO, Minapharm has established an integrated business model making it the only gene-to-market company in the region. Consolidating its international platform of intelligent biopharmaceutical technologies with the longstanding process development and manufacturing expertise in the MEA, Minapharm, together with ProBioGen, has incorporated MiGenTra GmbH headquartered in Berlin and manufacturing in Cairo, to enhance the accessibility to critical healthcare transforming medicines through product development and commercialization of Biosimilar mABs, Cell, and Gene Therapies and vaccines, at affordable prices in Egypt, and MEA.

Our Values:

• Diversity & Respect
• Integrity & Accountability
• Collaboration
• Leadership & Empowerment
• Innovation & Continuous Learning

Job Summary:

To monitor the environment in Sterile Department and share in qualification.

Job responsibilities:

1. Perform environmental monitoring activities in production sterile area during production process.
2. Perform area qualifications with different methods for sterile and non-sterile area.
3. Perform media fill test for all sterile production lines.
4. Monitor all temperature measuring devices (Data Logger) and ensure the results within limits and storage of the records and ensure calibration of Data Logger.
5. Collect a water samples and cleaning validation sample from the sterile area.
6. Participate in issuing and updating the SOPs relevant to sterile manufacturing.
7. Report the result of different tests.
8. Perform environmental test results for the area & trend analysis of data.
9. Perform any additional tasks as requested.

Qualifications:

• Bachelor degree in Pharmaceutical Sciences or Science (Microbiology).
• 6-9 years of experience in microbiology.

Trainings & knowledge:

Trainings :

• cGMP
• ISO 9001
• ISO 14001
• OHSAS 18001.
• ISO 14644

Knowledge:

• Basic cGMP guidelines.
• Basic Microbiology techniques
• System Awareness
• Awareness to of the general rules of good manufacturing practice
• Ability to cope with minimum knowledge of the microbiological testing techniques.
• Ability to implement of the integrated management system for (cGMP, ISO 9001, ISO 14001 & OHSAS 18001)

Location: 10th of Ramadan

Benefits

Transportation provided.

Medical Insurance.

Life Insurance.

Profit share.

Good Luck to All!