Process & Cleaning Validation Specialist - Fixed term (replacement for maternity leave)

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7h6oli

This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork - the largest global platform for the LGBTQ+ business community. Legga la panoramica di questa possibilità per capire quali competenze sono richieste, incluse le soft skill pertinenti e la padronanza di pacchetti software. Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Job Description 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 (through oversight during the validation batches, also during the week end if needed) 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. Ensure accurate execution of validation activities, through the accurate collect

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7h6oli