Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Purpose of the position/responsibility:
Support the Process & Cleaning Validation Team in ensuring the validation of business processes for production of sterile injectable medicines and cleaning of equipment, managed through validation and technical documents, in compliance with current regulations (GMP standards, FDA, Ema etc.)
Specific tasks/primary activities:
Validation documents: Issuing of validation documents relating to the manufacturing processes or cleaning procedures that must be validated, in order to acquire information necessary for the execution of the validation activities and the drafting of the validation reports , in compliance with the company procedures. Drafting technical documentation.
Participate in the project teams discussing technical aspects of the validation strategy to be submitted to the regulatory authorities. Write technical validation documentation, in compliance with corporate procedures.
Support the execution of operational activities from a technical point of view.
Review the data generated by the validation activities and their analysis, in compliance with the protocols and company procedures.
- Degree in Pharmacy, Chemistry, Biotechnology, Biology, similar scientific degrees or consolidated experience;
- Previous experience in validation is helpful;
- Proficient English (both written and spoken);
- IT knowledge: Company IT systems (PMX, LIMS, Trackwise, Minitab) and Microsoft Office tools;
- Personal skills: Excellent interpersonal skills, proactivity, ability to work in a team.
As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, tackle sophisticated scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
