When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $24 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
 
Location/Division Specific Information
The pharmaceutical manufacturing plant in Ferentino (80km from Rome), with more than 850 employees, is specialized in commercial contract manufacturing of injectable drugs, both liquid and lyophilized formulations, with an increasing focus on biologics.
 
How will you make an impact?
The candidate will support the team leader and his/her team colleagues ensuring the validation of FDA-approved sterile production processes and cleaning activities. S/he will be responsible for writing protocols, executing validation activities and writing validation reports, in compliance with cGMP, Clients’ needs and the Company's quality standards.
The Process & Cleaning Validation Specialist will be directly involved in Technology Transfer projects as a subject matter expert and will closely interact with our international clients.
We are looking for a highly motivated, result-driven professional, who is willing to take up an all-round role in an international environment and will actively contribute to the success of critical projects for the Ferentino Site.
 
What will you do?           
 

• Ensure the correct validation and cleaning project process, through the coordination and supervision of activities in compliance with protocols and procedures.
• Be responsible for the technical documentation analysis in order to obtain information that will help him/her to write protocols and validation reports and execute validation activities in compliance with company procedures, Clients’ needs and cGMP.
• Analyze generated data from validation activities and other internal functions, support the other internal function such as the Batch Record and Investigation Team during the handling of any deviations in accordance with protocols and business procedures.
• Ensure and work for the correct execution of Regolatory and Clients audits through the provision of necessary information and documentation.

• Knowledge of pharmaceutical process validation and main analytical methods
• Knowledge of GMP, pharmaceutical legislation and national and international guidelines
• At least 2 years of previous experience in similar role

• Communication skills
• Commercial orientation
• Ability to manage data and statistical analysis
• Fluent in Italian and English

 
At Thermo Fisher Scientific, each one of our 70,000 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.
 
Apply today! http://jobs.thermofisher.com
 
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.