Process & Cleaning Validation Specialit I

JOB DESCRIPTION

Work Schedule

Environmental Conditions

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.

DESCRIPTION:
Join us as a Validation Engineer at Thermo Fisher Scientific, where you'll contribute to ensuring product quality and regulatory compliance. You'll be responsible for planning, executing, and documenting validation activities across equipment, processes, and computer systems. Working with cross-functional teams, you'll help maintain our high standards of quality while supporting continuous improvement initiatives. This role offers excellent opportunities for professional growth within an established leader in serving science.

REQUIREMENTS:

• Evaluate manufacturing process documents or equipment cleaning procedures that must be subjected to validation, in order to acquire information for the definition of the protocols and the execution of the process ( both for product manufacturing and aseptic filling (Media fill)) and the cleaning validation of the procedures. Ensure periodic cleaning verification, as per SOPs and regulatory requirements.
• Draft of Validation Protocols (cleaning, Process, Media Fill), by acquiring information from other departments to define their contents (e.g. process parameters, sampling plan) as well as collaborating with company functions to define actions to be carried out, as per company procedures. Handle periodic cleaning validation and aseptic fillings (Media Fill). Ensure the drafting and/or updating of risk assessments for management of Cross Contamination.
• Ensure alignment with internal SOPs, through verification and supervision of the application of procedures of the areas of competence
• Validate the manufacturing processes (applying "Lifecycle approach" Stage 2 Process Qualification and Stage 3 Continued Process Verification), cleaning procedures and APS/Media Fill, collaborating with other departments in the operational activities envisaged by the Protocols. Support, in conjunction with other functions, in the drafting and approval of documents relating to new products in the transfer and validation phase. Handle deviations related to validation activities if necessary.
• Ensure accurate execution of validation activities, through the accurate collection and accurate analysis of the results generated
• Draft the Validation Reports, based on the results emerging from the validation activities.
• Ensure the accurate archiving of all documentation
• Provide quality support for the transfer of new products, through accurate participation in the various phases of the project up process performance qualification, assuring accurate GMP standards in force.
• Actively participating as SME in all design, construction and implementation phases of new processes or manufacturing departments. Additional tasks could be requested to support other Departments in accordance to indications received by the Management.

Education:

• Completion Bachelor’s Degree or its equivalent (depending on country) in a scientific/pharmaceutical area (FCT, Pharmacy, Chemistry, Biotechnology)

Technical skills

• Pharmaceutical techniques
• Pharmaceutical production
• Aseptic Filling processes
• Risk management
• Client service/ Project Management experience
• Knowledge of Microsoft Office software (i.e. word, Excel)

Professional Experience:

• Previous direct experience in Process Validation, Cleaning Validation, Aseptic Process Simulation (at least 1 year is preferable) for Sterile Products.
• Equivalent combinations of education, training, and relevant work experience may be considered (i.e. Manufactruing Technology)

Languages:

• Italian as basice and English : Advanced written and oral communication skills