Process & Cleaning Validation Specialist
3 settimane fa
Process & Cleaning Validation Specialist
Monza, Italy Full-Time Internal/External
**Location/Division Specific Information**
Monza (MB), Italy
As Process & Cleaning Validation Specialist, you will become part of a proactive and dynamic team, within the Quality Unit, which leads 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 collaboration 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 technical support will be important in manufacturing new life-saving sterile drugs.
A determined 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 finding 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;
- Close contact with Clients' technical and QA 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;
- Quality evaluation of process design features and filter validation aspects;
- On-the-floor overlooking of manufacturing activities;
- To ensure that new product introduction and all process changes are adequately evaluated and handled through change control management;
- Support in preparation and participation to Clients' and Regulatory audits with regards to validation activities.
- To ensure accurate management and archiving of validation documentation in line with GMP and internal procedures.
**Education**
- Degree in Pharmacy / CTF / Biological Sciences / Chemistry / Engineering / Biotechnology / Physics.
**Experience**
- At least 1-2 years of experience in pharmaceutical/chemistry industry;
- Experience in validation, preferably with liquid and lyophilized sterile injectables drugs will be considered as a plus.
**Knowledge, Skills, Abilities**
- Italian and English (at least B2) proficient;
- Knowledge of basic sterility assurance concepts and analytical methods (chemical and microbiological);
- Curious attitude;
- Good interpersonal skills and ability to work in multi-disciplinary teams.
At Thermo Fisher Scientific, each one of our 70,000 outstanding minds has a unique story to tell. Join us and give to our extraordinary mission—enabling our customers to make the world healthier, cleaner and safer.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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