- Perform all functions associated with process validation support, with a specific focus on CPV
- Establish global CPV initiatives and standard practices
- Act as the primary biostatistician in supporting Process Engineering and Process Development DoE studies
- Manage the scope, schedule, and reporting of CPV program activities
- Participate in Customer and Regulatory Audits
- Draft, review, and approve CPV plans, CPV reports, and APQRs
Requirements :
- Bachelor's degree in a scientific field, preferably an engineering field
- 5+ years of experience in the GMP regulated Biologics / Pharma Industry or equivalent (or master's degree + 2 years' experience or
- Strong foundation in general scientific practices, principles, and concepts
- Excellent written and verbal communication skills
- Ability to work independently and collaboratively as part of a team
- Proficiency in statistical analysis software programs such as JMP
- Proficient in Microsoft Word and Excel
Thermo Fisher Scientific is proud to be an Equal Opportunity Employer. We value diversity and believe that a multitude of perspectives leads to world-class innovation.
We are committed to providing a safe, inclusive, and collaborative work environment where all individuals are treated with respect and are able to thrive.
If you require any accommodations during the job application process due to a disability, please contact us at 1-855-471-2255*.
We offer accessibility services for individuals with various impairments and will provide the necessary support to ensure a smooth application process.
Please include your contact information and specific details about your required accommodations in your request.
Don't miss this incredible opportunity to join our team and contribute to our mission of making the world healthier, cleaner, and safer.
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