Sterility Assurance Lead

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Location/Division Specific Information

Ferentino,IT / DPD EU

How will you make an impact?

In this role you will be responsible to ensure, in collaboration with the Sterility Assurance Manager, that the production processes for the manufacture of sterile injectable drugs are conducted with the necessary robustness and in compliance with the appropriate Sterility Assurance standards, with the requirements of current GMP regulations and related internal procedures and Corporate Standards.

Key responsibilities include:

- Definition and implementation of appropriate contamination control strategies (CCS - Contamination Control Strategies) at the site level. He/She is responsible for the drafting of the CCS as well as for its periodic review, in order to guarantee its continuous maintenance / updating over time;
- Contributing to the definition of the site EM monitoring program and for verifying its effectiveness over time through the periodic assessment of environmental trends;
- Issue and review of risk assessments, protocols and reports for the environmental validation / revalidation activities (EMPQ) within the planned due dates;
- Collaborate with the Sterility Assurance Manager to define the aseptic process simulation strategies (APS - Aseptic Process Simulation);
- Issue and review of the related documentation (Annual Plans, Risk Assessments, protocols and reports) within the planned due dates;
- Coordinate / carry out surveillance and supervision activities foreseen by the APS program;
- Collaborate with the Sterility Assurance Manager in assigning priorities and activities to the Sterility Assurance team;
- Coordinate / train personnel on aspects of Sterility Assurance (e.g. behavioral rules in classified areas, AVS (Airflow Visualization Studies), aseptic techniques);
- Work in collaboration with the various site functions, for the drafting and review of risk assessments aimed at assessing any gaps found in the processes and / or at the plant / utilities level with respect to current and future regulations (Continuous Improvement);
- Carry out the impact assessment as part of the deviation investigations that impact the sterility assurance status of production departments (e.g. Adverse EM trends, media fill failures, sterility failures) actively participating in the definition of corrective / preventive actions;
- Review and approve Minor / Major Deviations, review critical deviations and evaluate any Change Proposal impacting Sterility Assurance;
- Receive constant training on GMPs in sterility assurance and transfer this training to site SMEs (at least 10% of their time);
- Act as site SME for sterility assurance aspects during regulatory and / or customer audits
- Act as a site SME for sterility assurance evaluation for the introduction of new products and for new projects (for example: new lines / processes);
- Periodically assess compliance with regulatory requirements in force (Annex 1 and FDA guideline) and future updates, evaluating any GAPs and guiding the implementation of the best practices identified in terms of Sterility Assurance;
- Represent the Site in the Sterile Working Groups by harmonizing the practices / procedures / processes between the various sites of the network;
- Collaborate to promote Sterility Assurance activities / initiatives with the Site Leadership Team and through company board meetings (e.g. Quality Council, Town Hall, Management Review);
- Perform Audits at other sterile sites and providers of microbiological services and / or sterile materials (where required)

How will you get here?

**Education**:

- Master’s degree in biology or other relevant scientific disciplines.

**Experience**:

- 5+ years of experience in production plants with specific focus on manufacturing techniques in asepsis / terminal sterilization processes.

Knowledge, Skills, Abilities
- Solid background and consolidated knowledge on sterility assurance aspects and contamination control strategy.
- Knowledge of cGMPs, with specific focus in the area of sterile products manufacturing (EU/US), and of relevant international standards and guidelines (ICH / PDA / ISPE).
- Good knowledge of English language, both oral and written (at least European Level B2)
- Strong interpersonal and communication skills
- Ability to influence others in a matrix environment
- Ability to work under mínimal supervision
- Ability to adapt to constantly changing environment, reprioritizing tasks and activities
- Proactivity, flexibility, teamwork

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