Equipment Validation Lead
7 mesi fa
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.
**How will you make an impact?**
You will join the site Equipment Validation Team, a smart, fast paced and result oriented environment where you will work with mínimal supervision on multiple projects and new products introduction.
**What will you do?**
- Ensure, in agreement with the manager, the analysis and evaluation of the documentation relating to the plants that must undergo qualification or requalification in order to acquire all the details necessary to issue the protocols and to implement validation activities.
- Draw up Qualification/Requalification Documents (IQ-OQ-PQ Protocols), through the research and acquisition of the data and information necessary to define their contents as well as involving the corporate functions in relation to the definition of the tests they will have to carry out.
- Ensure the accurate qualification/requalification of plant and equipments, through the execution of the operational activities envisaged by the Protocols (IQ-OQ-PQ Protocols) and the coordination of the activities carried out by the other company functions, in compliance with the company protocols and SOP.
- Carry out an accurate analysis of data collected during qualification activities, through the collection of data and the results generated, according to ThermoFisher scientific protocols and standard procedures.
- Issue Qualification Reports (IQ-OQ-PQ Report), based on the accurate analysis of all the data recorded during validation activities, in compliance with company protocols and procedures.
- Carry out the accurate archiving of all the documentation produced during qualifications activities, issuing validation dossiers ensuring their accurate traceability
- Support QA Compliance in preparing for and participating in audits by regulators or customers, providing necessary information and documentation. If requested by QA Compliance, according with the Supervisor, actively participate regulatory or customers audits.
**How will you get here?**
- Degree in CTF, Industrial Chemistry, Engineering or other similar fields
- Experience in pharmaceutical industries
- Multi-year experience in Validation of equipment for Sterile Injectable products
**Knowledge, Skills, Abilities**
- Good knowledge of GMP qualification process and documentation
- Strong written and verbal communication.
- Interpersonal cross functional team based interaction.
- Analytical thinking, planning and problem solving skills
At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
-
Equipment Validation Lead
9 mesi fa
Ferentino, Italia Thermo Fisher Scientific A tempo pieno**Job tasks**: **Analysis of the technical documentation**: Ensure, in agreement with the manager, the analysis and evaluation of the documentation relating to the plants that must undergo qualification or requalification in order to acquire all the details necessary to issue the protocols and to implement validation activities. **Protocol...
-
Specialist, Equipment Validation
2 settimane fa
Ferentino, Italia Thermo Fisher Scientific A tempo pieno**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Location/Division Specific Information**: Ferentino, Italy **Discover Impactful Work**: Ensure the execution of the qualification activities of the Site Equipment reported in the written protocol. Assure the tests are in line with the main guidelines and GMP. **A day in the...
-
Equipment Validation Specialist
9 mesi fa
Ferentino, Italia Thermo Fisher Scientific A tempo pienoAnalysis of the technical documentationEnsure, in agreement with the Supervisor, the analysis and evaluation of the documentation relating to the plants that must undergo qualification or requalification in order to acquire all the details necessary to issue the protocols and to implement validation activities. - Protocol definitionDraw up...
-
Equipment Validation Specialist
9 mesi fa
Ferentino, Italia Thermo Fisher Scientific A tempo pieno**Analysis of the technical documentation**: Ensure, in agreement with the Supervisor, the analysis and evaluation of the documentation relating to the plants that must undergo qualification or requalification in order to acquire all the details necessary to issue the protocols and to implement validation activities. **Protocol definition**: Draw up...
-
Equipment Validation Specialist
5 mesi fa
Ferentino, Italia Thermo Fisher Scientific A tempo pienoAnalysis of the technical documentationEnsure, in agreement with the manager, the analysis and evaluation of the documentation relating to the plants that must undergo qualification or requalification in order to acquire all the details necessary to issue the protocols and to implement validation activities. - Protocol definitionDraw up...
-
Equipment Validation Specialist
5 mesi fa
Ferentino, Italia Thermo Fisher Scientific A tempo pieno**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Analysis of the technical documentation**: Ensure, in agreement with the manager, the analysis and evaluation of the documentation relating to the plants that must undergo qualification or requalification in order to acquire all the details necessary to issue the protocols and to...
-
Equipment Validation Specialist
4 settimane fa
Ferentino, Italia Thermo Fisher Scientific A tempo pieno**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office At Thermo Fisher Scientific team, you’ll discover impactful work, 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...
-
Ferentino, Italia Thermo Fisher Scientific A tempo pieno**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office About Thermo Fisher Scientific Inc. Thermo Fisher Scientific Inc. is a global leader in serving science, with a mission to enable our customers to make the world healthier, cleaner, and safer. As one team of 100,000+ colleagues, we are committed to accelerating research, solving...
-
Process & Cleaning Validation Specialist II
4 settimane fa
Ferentino, Italia Thermo Fisher Scientific A tempo pienoWork Schedule Standard (Mon-Fri) Environmental Conditions Office Job DescriptionAbout Thermo Fisher Scientific Inc.Thermo Fisher Scientific Inc. is a global leader in serving science, with a mission to enable our customers to make the world healthier, cleaner, and safer. As one team of 100,000+ colleagues, we are committed to accelerating research, solving...
-
Engineering Lead
2 mesi fa
Ferentino, Italia Thermo Fisher Scientific A tempo pieno**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office The Engineering Lead is responsible for the planning and management of engineering projects. Specifically, this role involves the coordination, monitoring, and planning of the project, as well as forecasting its costs and predicting the timing and deadlines that characterize its...
-
Csv Specialist
5 giorni fa
Ferentino, Italia Thermo Fisher Scientific A tempo pienoEnsure the execution of validation activities for CSV projects according to the timeline, procedures and the priorities defined by the company - Lead cross functional team and external personnel on assigned projects as defined within the Proactive Quality plan - Draft the main validation documents (URS, plans, risk analysis, test protocols and reports) in...
-
Manufacturing Sterile Lead Dps
3 mesi fa
Ferentino, Italia Thermo Fisher Scientific A tempo pieno**Work Schedule** Other **Environmental Conditions** Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. And you’ll have the opportunity for continual growth and learning in a culture that empowers your...
-
Supervisor, Calibration
5 mesi fa
Ferentino, Italia Thermo Fisher Scientific A tempo pieno**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Thermo Fisher Scientific is currently seeking a Supervisor, Calibration and requalification to join our team in Italy. This is an exceptional opportunity for a bold and curious individual with confirmed experience in the pharmaceutical industry. As the Supervisor, you will play a...
-
Qc Technician Ii
8 mesi fa
Ferentino, Italia Thermo Fisher Scientific A tempo pienoThis position is responsible for performing quality control testing of raw material, API / DS, semi-finished and finished products (Release and Stability) in accordance with the shipping schedule and production requirements to ensure high levels of customer service delivery. **Responsibilities**: - To use and controls equipment for analysis in the...
-
Pds Analytical Development
8 mesi fa
Ferentino, Italia Thermo Fisher Scientific A tempo pieno**Position Summary**: This position is responsible for performing quality control testing of raw material, API / DS, semi-finished and finished products (Release and Stability) in accordance with the shipping schedule and production requirements to ensure high levels of customer service delivery. **Responsibilities**: - To use and controls equipment for...
-
Quality Qualification Specialist
7 mesi fa
Ferentino, Italia Thermo Fisher Scientific A tempo pieno**How will you make an impact?** Ensure the Quality of the Technical Area Departments, dealing in particular with the management of Customer Audits and Regulatory Inspections, Deviations, CAPAs, Changes, SOPs relating to Process Maintenance and Utilities, Calibrations and Equipment Qualification. **What will you do?** - Support the Quality Department in...
-
Pds Analytical Development
8 mesi fa
Ferentino, Italia Thermo Fisher Scientific A tempo pienoAccording to the tasks received from the manager, yoou will perform the activities listed for which the employee has been enabled by appropriate training, in compliance with Corporate and departmental SOPs and safety regulations. ASSIGNMENTS, SPECIFIC/PRIMARY ACTIVITIES: - uses and controls equipment for analysis in the laboratory. - deals with the...
-
Pds Analytical Development
9 mesi fa
Ferentino, Italia Thermo Fisher Scientific A tempo pienoAccording to the tasks received from the manager, he performs the activities listed for which the employee has been enabled by appropriate training, in compliance with Corporate and departmental SOPs and safety regulations. He uses and controls equipment for analysis in the laboratory. He deals with the chemical analysis of raw materials, semi-finished...
-
Sterility Assurance Lead
2 settimane fa
Ferentino, Italia Thermo Fisher Scientific A tempo pienoWhen 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...
-
Sterility Assurance Manager
9 mesi fa
Ferentino, Italia Thermo Fisher Scientific A tempo pienoAt 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...