Aseptic Process Validation Specialist

Work Schedule

Environmental Conditions

Job Description

Purpose of position/responsibility:

Support the Supervisor, MS&T Process & Cleaning 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 scientific degrees or consolidated experience;
• Previous experience in validation is helpful;
• Proficient English (both written and spoken);
• IT knowledge: Company IT systems (PMX, LIMS, Trackwise, Minitab) and Microsoft Office tools;
• Personal skills: Excellent interpersonal skills, proactivity, ability to work in a team.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.