Process Cleaning Validation Specialist
Process Cleaning Validation Specialist
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Job Description
Work Schedule
Standard (MonFri)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 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 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.
Requirements and qualifications:
- 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.
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.
As one team of 100000 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.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
