
Biotechnology Validation Specialist
9 hours ago
We are seeking a skilled Biotechnology Validation Specialist to join our team at Thermo Fisher Scientific. As a key member of our operations, you will be responsible for providing specialized validation knowledge and information to support our clients and internal teams.
The successful candidate will have a strong background in validation, process engineering, or quality within the pharmaceutical or biotechnology industry. A Bachelor's or Master's degree in chemistry, pharmacy, engineering, biotechnology, or a related field is required, with a minimum of 3 years of experience in a relevant role.
Key Responsibilities- Design and implement validation strategies for processes, packaging, and cleaning validation.
- Prepare and review validation protocols and reports for various studies, including process, packaging, and cleaning validation.
- Monitor and coordinate manufacturing execution, providing training on validation protocols as needed.
- Analyze data, perform statistical analysis, and prepare summary reports.
- Lead annual monitoring programs for cleaning and manage site cleaning matrices.
- Coordinate swab sampling activities for cleaning validation and perform risk assessments for equipment and procedures.
- Develop and maintain risk assessment protocols, reports, and Continued Process Verification programs.
- Collaborate with clients, project managers, and stakeholders to drive validation activities forward.
- Bachelor's or Master's degree in chemistry, pharmacy, engineering, biotechnology, or a related field.
- Minimum 3 years of experience in validation, process engineering, or quality within the pharmaceutical or biotechnology industry.
- Strong written and oral communication skills, with attention to detail and accuracy.
- Excellent interpersonal skills, with ability to work collaboratively and communicate effectively with diverse stakeholders.
- Proficiency in Microsoft Office programs and Mini-Tab data analysis software.
- Demonstrated computer proficiency and English language skills.
As a Biotechnology Validation Specialist at Thermo Fisher Scientific, you will enjoy a competitive salary range of $80,000 - $110,000 per year, based on experience and location. Our comprehensive benefits package includes medical, dental, and vision insurance, 401(k) matching, paid time off, and opportunities for professional growth and development.
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