Aseptic Process Validation Specialist

Are you passionate about ensuring the safety and efficacy of pharmaceutical products? Are you experienced in aseptic process validation and looking for a new challenge? Thermo Fisher Scientific is seeking a highly skilled Aseptic Process Validation Specialist to join our team. In this role, you will play a critical role in ensuring the quality and compliance of our manufacturing processes. We are looking for someone who is detail-oriented, collaborative, and dedicated to upholding the highest standards in the industry. If this sounds like you, read on for more details about this exciting opportunity.

1. Develop and execute aseptic process validation protocols in compliance with regulatory requirements and company standards.
2. Conduct risk assessments to identify potential hazards and implement appropriate mitigation strategies.
3. Monitor and analyze data to ensure process parameters are within acceptable limits and make recommendations for process improvements.
4. Collaborate with cross-functional teams including R&D, Quality, and Operations to ensure validation activities are aligned with project timelines and goals.
5. Prepare and review validation reports, protocols, and other relevant documentation to support regulatory submissions.
6. Lead investigations into deviations or failures in the aseptic process and provide root cause analysis and corrective actions.
7. Stay current with industry trends and regulatory requirements related to aseptic processing and incorporate best practices into validation processes.
8. Train and mentor team members on aseptic processing techniques and validation procedures.
9. Maintain and update validation master plans and standard operating procedures (SOPs) related to aseptic process validation.
10. Contribute to continuous improvement initiatives and participate in audits and inspections by regulatory agencies.
11. Communicate effectively with internal and external stakeholders regarding validation activities and results.
12. Ensure all activities are conducted in a safe and compliant manner, in accordance with company policies and procedures.

According to JobzMall, the average salary range for a Aseptic Process Validation Specialist in 20900 Monza, Province of Monza and Brianza, Italy is €45,000 - €65,000 per year. However, salaries may vary depending on the individual's experience, education, and the specific company they are working for. It is also important to note that the cost of living in Monza and the surrounding area may also affect salary ranges.

Thermo Fisher Scientific is a U.S.-based provisioner of scientific instrumentation, reagents and consumables, and software and services to healthcare, life science, and other laboratories in academia, government, and industry.