Process / Cleaning Validation Specialist II – Hiring Now

We are in search of an analytical Process & Cleaning Validation Specialist II to join our dedicated team at Thermo Fisher Scientific in Frosinone (FR). Growing your career as a Full Time Process & Cleaning Validation Specialist II is a fantastic opportunity to develop relevant skills. If you are strong in presentation, teamwork and have the right talent for the job, then apply for the position of Process & Cleaning Validation Specialist II at Thermo Fisher Scientific today Analysis of the technical documentation – Ensure the analysis and evaluation of the technical documentation relating to the manufacturing processes or cleaning procedures of the equipment that must be subjected to validation, in order to acquire information necessary for the definition of the protocols and the execution of the process validation activities ( both for product manufacturing and aseptic filling (Media fill) and the validation of cleaning procedures. Ensure periodic verification of cleaning procedures, in compliance with company procedures and regulatory requirements. Definition of protocols – Ensure the drafting of Validation Protocols (cleaning, Process, APS/Media Fill), through research and acquisition from other departments of the data and information necessary to define their contents (e.g. process parameters, sampling plan) as well as involving company functions in relation to the definition of the activities they will have to carry out, in compliance with company procedures. – Ensure periodic validation of cleaning procedures and aseptic fillings (APS/Media Fill) in compliance with company procedures and regulatory requirements -Ensure the drafting and/or updating of risk assessments relating to the management of Cross Contamination. Quality – Ensure compliance with company quality standards, through verification and supervision of the application of procedures relating to the areas of competence, in compliance with company quality policies and procedures. Validate – Ensure the correct validation of manufacturing processes (in accordance with the “Lifecycle approach” Stage 2 Process Qualification and Stage 3 Continued Process Verification), cleaning procedures and APS/Media Fill, supervising other departments in the operational activities envisaged by the Protocols in compliance with company protocols and procedures. Support, in conjunction with other functions, in the drafting and approval of documents relating to new products in the transfer and validation phase. Manage deviations related to validation activities if necessary. Data analysis Ensure correct analysis of validation activities, through the collection and analysis of the data and results generated, in compliance with company protocols and procedures. Validation reports Ensure the correct drafting of Validation Reports, based on the analysis of the data emerging from the validation activities, in compliance with company protocols and procedures. Validation report archiving – Ensure the correct archiving of all documentation relating to validations, through the preparation of validation dossiers. Tech Transfer Provide quality support for the transfer of new products, through participation in the various phases of the project up to validation activities, supervising and contributing to the definition, application and surveillance of the GMP standards in force. Project management Actively participating as an expert in all design, construction and implementation phases of new processes or manufacturing departments. , Furthermore, depending on the needs of the Department and in accordance with the indications of the P&C Val Supervisor, he supports the rest of the team (for example, APR). Audits – Provide support in the preparation of audits by Customers and regulatory agencies, through the provision of necessary information and documentation and possible participation in the audits themselves, in compliance with current GMP regulations. Change – Support the Supervisor in evaluating change controls and implementing the related actions, in compliance with company needs and procedures. Education: Completion of a 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: Requires at least 2 years of previous related experience and a general knowledge of Pharmaceutical Industry experience. 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 Benefits of working as a Process & Cleaning Validation Specialist II in Frosinone (FR): ● Learning opportunities ● Room for Advancement ● Advantageous package J-18808-Ljbffr