Process and Cleaning Validation Specialist

4 giorni fa

Monza, Italia Thermo Fisher Scientific A tempo pieno

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**

Monza (MB)

**How will you make an impact?**

As Process & Cleaning Validation Specialist, you will become part of a proactive and dynamic team, within the Quality Unit, which is responsible for the process validation of new products manufacturing in Monza site, supervising on the floor operations, acting as primary reference contact for the internal departments and for Clients. Process & Cleaning Validation Specialist is a key element for the Company core business. The cooperation with Project Managers, Process Engineers and Client technical teams, is the key for the successful transfer of new processes in Thermo Fisher Monza Site.

**What will you **do?**

You will join the Process & Cleaning Validation Team, spearhead of Manufacturing Science & Technology department of the Quality Unit.

In this role you will lead client’s projects from a validation standpoint for what concerns the manufacturing process and cleaning activities, assisting Technology Transfer Project Managers on customer technical transfers, modifications to existing processes or adding new processes that will improve process safety, reduce plant operating costs as well as improve product quality and efficacy. Ultimately your quality and technical support will be essential in manufacturing new life-saving sterile drugs.

A goal-driven attitude will be key in meeting Regulatory expectations and in exceeding client’s expectations. A strong technical mindset and the ability to “think outside the box” will be fundamental in setting the troubleshooting that allows you to find new solutions to problems.

The main activities you will be involved in are:

- To follow the technology transfer phases from the initial project Kick-off to the commercial readiness as a point of reference for Qualitative and Validation technical aspects;
- To work in close contact with Clients’ technical and quality teams to develop a robust validation strategy in accordance with Client’s expectations and requirements;
- To issue Process and Cleaning Validation protocols and reports for clinical, registration and validation batches manufacturing, in accordance with GMP and corporate standards;
- To provide Qualitative and Technical recommendations to permit plant operation within regulatory requirements (FDA, EMEA, AIFA, etc.);
- To support in drawing manufacturing instructions (MBR) or cleaning procedures (SOP) which need to be validated;
- To support in quality evaluation of process design features and filter validation aspects;
- To overlook manufacturing activities related to clinical, registration and validation batches;
- To ensure that new product introduction and all process changes are adequately evaluated and managed through change control management;
- To support in preparation and participation to Clients’ and Regulatory audits with regards to validation activities.
- To ensure correct management and archiving of validation documentation in line with GMP and internal procedures.

**How will you get here?**
- Degree in Pharmacy / CTF / Biological Sciences / Chemistry / Industrial chemistry / Chemical engineering / Biotechnology
- At least 1-2 years of experience in validation in pharma/chemistry industry
- Experience in validation, preferably with liquid and lyophilized sterile injectables drugs will be considered as a plus.

**Knowledge, Skills, Abilities**
- English and Italian fluent (at least B2)
- Knowledge of basic sterility assurance concepts
- Knowledge of basic analytical methods (chemical and microbiological)
- Curious mindset;
- Good communication skills and ability to work in multi-disciplinary teams.

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