Aseptic Process Validation Specialist
Pubblicato il 12-09-2026 - Thermo Fisher Scientific in Monza
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Support the Team Leader, Aseptic Process Validation in ensuring the management of the aseptic process validation: The resource will become part of a multi-layered and dynamic team, which is accountable for the aseptic process validation of products’ manufacturing in Monza site, by leading Aseptic Process Simulation (APS) documentation and guide on the floor operations, in close contact with technical and sterility assurance teams, and in accordance with Regulatory mentorship.
Aseptic Process Validation Specialist is a key element for the Company core business. Participating with Project Managers, Process Validation, and Client Technical teams, they also support to the Quality/Sterility Assurance Unit at the Monza site in reach the Company goal.
Specifics task and primary activities:
- Issuing validation procedures, protocols and reports for Media Fill exercises
- Processes design: Object of APS are manufacturing of sterile lyophilized and liquids drug products (vials, pre-filled cartridges or syringes),
manufactured under RABS systems or isolators;
- Analysis of technical documentation related to new product introduction;Issue of manufacturing instructions (MBR) for validation batches;
- Ensure that our client service delivery performance is maintained at the highest level, by encouraging positive relationships with our clients and coordinating activities to ensure the clients are kept informed in a timely manner.
- Issue of technical reports and risk assessments related to operator qualification, qualified holding times, aseptic interventions
- Guarantee that all relevant activities are adequately evaluated and handled through change control management
- Clients’ and Regulatory audits with regards to Media Fill activities.
- Ensure an adequate reporting to the Area Management about potential issues
Requirements and qualifications:
- Degree in Pharmacy, Chemistry, Biotechnology, Biology, similar