CSV Specialist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

• As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer! We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
• Are you ready to collaborate with the expert CSV team to guarantee the compliance of Information Systems installed in Patheon Monzato the National and International guidelines (NBF/EU Annex/GMP)?

Main responsibilities:

Assure the execution of the validation projects, within the timeline and the modality defined upon the priorities by the site management.

Edit and review validation documents (specification documents, risk analysis and validation protocols) in agreement with the site procedures.

Work with other sites’ functions and external contractors to complete the validation tasks in agreement to the High Quality Standard

Define standards to ensure the validation of the computerized system according to the local and corporate guidelines.

Issue and update the local procedures aligned to the guideline and the corporate standards

Coordinate contractors and suppliers for the completion of the validation activities.

Competencies:

Computer Science/Scientific Degrees or equivalent experience

GMP/GAMP knowledge

Computer Systems validation guidelines

Word, Excel, MS Project

Previous experience in information systems validation

Hybrid site/remote work offered.

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 complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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.

Read Full Description