Process & Cleaning Validation Specialist

7 giorni fa

Ferentino, 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?**

The resource will become part of a lively and dynamic team which is responsible for the validation process of new products’ manufacturing in Monza site, by managing Process and Cleaning Validation documentation and supervising on the floor operations, in close contact with Client’s technical and quality teams, and in accordance with Regulatory guidance.

Process and Cleaning validation specialist is a key element for the Company core business. P&C validation specialist cooperates with Project Managers, Process Engineers and Client technical teams, within Monza site Quality Unit, for the successful transfer of new processes in TF Monza Site.

**What will you do?**:

- Analysis of technical documentation related to manufacturing instructions or cleaning procedures which need to be validated, in order to collect the necessary information for the definition of protocols and execution of validation activities;
- Issuing of Process and Cleaning Validation protocols and reports for clinical, registration and validation batches manufacturing, in accordance with GMP and corporate standards; Collect necessary information by involving relevant functions. Processes object of validation are: manufacturing of sterile lyophilized and liquids drug products (vials, pre-filled cartridges or syringes) and secondary packaging processes (labeling and serialization steps), as well modern pharmaceutical technologies (i.e. fill finish processes under isolators);
- Ensure correct management and archiving of validation documentation in line with GMP and internal procedures;
- Support in drawing manufacturing instructions (MBR) for clinical, registration and validation batches;
- Support in quality evaluation of process design features and filter validation aspects;
On-the-floor overlooking of manufacturing activities related to clinical, registration and validation batches;
- Support in preparation and update of Process and Cleaning Validation Master Plans, in accordance with Regulatory guidance, indications included in dossiers and Company Quality Standards.
- Ensure that new product introduction and all process changes are adequately evaluated and managed through change control management
- Ensure that process and cleaning validation activities are carried out in accordance with current Regulatory expectation and that the quality of the GMP batches meets the requirements by coordinating relevant functions and ensuring a timely management of unexpected events.
- Support in preparation and participation to Clients’ and Regulatory audits with regards to validation activities.
- Ensure that our client service delivery performance is maintained at the highest level, by building strong relationships with our clients and coordinating activities to ensure the clients are kept informed in a timely manner.
- 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
- Ensure an adequate reporting to the Area Management about potential validation issues and project status
**How will you get here?**
- Degree in Pharmacy / CTF / Biological Sciences / Chemistry / Industrial chemistry / Chemical engineering / Biotechnology
- At least 2-3 years of experience in validation in pharma/chemistry industry
**Knowledge, Skills, Abilities**
- English and Italian fluent
- Knowledge of basic sterility assurance concepts
- Knowledge of pharmaceutical legislation and national/international laws
- Knowledge of main analytical methods (chemical and microbiological)
- Good social skills, team working
- Propension to preparation and evaluation of technical documentation
- Critical sensibility, attention to details, precision
- Organizational skills

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