Sterility Assurance Expert

At Thermo Fisher Scientific team, you’ll discover impactful job, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our products are safe. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our dedication to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building an exciting career with us.

**Ferentino, Italy | Quality**

Discover Impactful Work:
The resource will be part of a very stimulate environment and will assure that the production processes for the manufacturing of sterile injectable drugs are conducted with robustness and in compliance with the appropriate standards of Sterility Assurance, the current GMP regulations, the internal procedures and Corporate Standards.

The role will:

- contribute to the definition and implementation of appropriate contamination control strategies (CCS) and he will assure their lifecycle management.
- Support the definition of Aseptic Process Simulation validation/revalidation activities, issuing the APS annual plan and the EM monitoring program assessment.
- Execute training and oversight of activities related to asepsis/terminal sterilization processes
- Provide support in the evaluation of investigations that impact the aseptic techniques and actively participating in the identification of corrective/preventive actions.
- Receive constant training on GMP in the field of Sterility Assurance and transfer this training to the site SMEs.
- Act as SME during regulatory and customer audits and new project introduction.

**Keys to Success**:
**Education**
- Minimum Bachelor’s degree required. Chemical, Scientific/Technical field such us Biology/Biotechnology, Chemistry, Pharmacy.

**Experience**
- Proven experience in similar position within a regulated environment such as, pharmaceutical or biotech companies.

**Knowledge, Skills, Abilities**
- Knowledge of global cGMP
- Knowledge of pharmaceutical laws (EU/US), and quality management system
- Experience in quality event management
- Manufacturing and validation knowledge
- Communication skills
- Understanding of the manufacture processes and aseptic validation

**Personality traits**:

- Problem solving
- Negotiation skills
- communication & negotiation skills

**Languages**:

- English

**Technical skills**
- GMP regulation (EU and US);
- Specific knowledge of Sterile injectable drugs production processes
- Sourced from Pharma FDA approved companies;
This is an equal opportunity employer : here in Thermo Fisher celebrates diversity and it is committed to crafting an inclusive environment for all employees