Process & Cleaning Validation Specialist II
As the world leader in serving science, our work is more than something that fills our days – what we do has great purpose. Our industry-leading scale means unparalleled commercial reach, unique customer access and a global footprint. Our broad customer base, from research to clinical to commercial production means you can have a broad and meaningful impact here at Thermo Fisher Scientific. All while working in an environment where you will be supported, valued and rewarded for your performance.
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, growing efficiency in their laboratories, improving patient health through diagnostics, or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience, and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.
Process & Cleaning Validation Specialist II
As a Process & Cleaning Validation Specialist II at Thermo Fisher Scientific, you will have the opportunity to be part of a world-class team and contribute to the flawless validation of manufacturing processes and cleaning procedures. Your expertise and proven experience will play a crucial role in ensuring the production of high-quality pharmaceutical products that meet strict regulatory requirements.
Responsibilities
- Evaluate manufacturing process documents and equipment cleaning procedures for validation purposes
- Develop protocols and conduct process validation for product manufacturing and aseptic filling (Media fill)
- Perform cleaning validation of cleaning procedures and ensure periodic cleaning verification
- Manage validation protocols for cleaning, process, and Media Fill
- Collaborate with other departments to define protocol contents and actions to be carried out
- Validate manufacturing processes, cleaning procedures, and APS/Media Fill
- Support the drafting and approval of documents for new product transfer and validation
- Handle deviations related to validation activities
- Ensure accurate execution of validation activities and detailed analysis of results
- Draft validation reports and ensure proper archiving of all documentation
- Provide quality support for new product transfer and process qualification
- Actively participate in the design, construction, and implementation of new processes or manufacturing departments
Requirements
- Bachelor's Degree or equivalent in a scientific/pharmaceutical area
- 2 years of previous related experience in the pharmaceutical sector
- Knowledge of pharmaceutical techniques, production, and aseptic filling processes
- Experience in risk management and client service/project management
- Proficiency in Microsoft Office software
- Fluent in English with advanced written and oral communication skills
Work Schedule
- Standard (Mon-Fri)
Environmental Conditions
- Office
