Process & Cleaning Validation Specialist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job 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:

1. Issuing validation documents relating to the manufacturing processes or cleaning procedures that must be validated, to acquire information necessary for the execution of the validation activities and the drafting of the validation reports, in compliance with the company procedures.
2. Drafting technical documentation.
3. Participating in project teams discussing technical aspects of the validation strategy to be submitted to the regulatory authorities.
4. Writing technical validation documentation, in compliance with corporate procedures.
5. Supporting the execution of operational activities from a technical point of view.
6. Reviewing 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 in 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 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.