Aseptic Process Validation Specialist
Aseptic Process Validation Specialist
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Job Description
Work Schedule
Standard (MonFri)Environmental Conditions
OfficeJob 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 multilayered 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 prefilled 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.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
