Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com
 
You will join the Process & Cleaning Validation team, within the QA function, to support the team in ensuring the validation of FDA-approved sterile production processes and cleaning activities. You 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 Monza Site. In this role you will gain an unmatched experience in technology transfers of sterile injectable products that will be invaluable for your next career step in our organization.


Essential Functions
 

• 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.
• Manage deadlines, change control activities and corporate procedures related to the whole production process, systems, products.
• Ensure and work for the correct execution of external audits through the provision of necessary information and documentation.

• Knowledge of pharmaceutical processes validation and main analytical methods
• Knowledge of GMP, pharmaceutical legislation and national and international guidelines
• Fluent English (written and spoken)
• At least 3 years of previous experience in similar role

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds have a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.