Scientist III, Manufacturing Sciences

Job Description

We are searching for a Continued Process Verification (CPV) Engineer 3 with education and experience in biopharmaceutical processing or a related field. This member of our team provides technological and statistical input in the validation and continued process verification of manufacturing processes. A CPV Engineer 3 routinely supports the Manufacturing Sciences and Technology team as a domain expert in statistics and data analysis. This role will collaborate internally with Process Engineers, Quality Assurance, and Regulatory. These activities are conducted in projects and involve teamwork with guides across functional groups to ensure project success. 

What will you do?

• Perform all functions associated with process validation support, specifically focusing on Continued Process Verification (CPV).
• Establish Global CPV initiatives and standard practices.
• Act as primary biostatistician in helping to support Process Engineering and Process Development DoE studies for Tech Transfer, Optimization, in-process controls, and general research and development.

• Chip in to Internal and Customer meetings based upon sound evidence guided by minimal supervision. 

• Handles internal projects and tasks and lead client projects and handle timelines with minimal support from supervision. 
• Actively identify error proofing opportunities and initiate and drive engineering initiatives to improve practices and procedures with minimal supervision. 
• Provide scientific expertise for GMP deviations by assessing, reviewing, and approving the impact of major deviations on both the product quality and the validation of the process. 
• Lead the scope, schedule, and reporting of CPV program activities for individual products and/or clients; ensure status, risks, and open issues are tracked and that all collaborators are informed of changes.
• Participate in Customer and Regulatory Audits. Regularly interact with site and global leadership on matters concerning several functional areas and/or customers.
• Draft, review, and approve CPV plans, CPV reports, APQRs, and other process documentation.
• Reviews, analyzes and trends process data without supervision
• Provide data, analyses, write-ups, reviews, and other guidance to annual product reviews (APR).
• Support our MSAT team with additional tasks to improve the site, ensure patient safety, and deliver for our customers. 

• Provides development and training for Process Engineers/Scientists.

How will you get here?

Education

• Bachelor’s degree required in a scientific field, preferably an engineering field. 
• 5+ years of experience in GMP regulated Biologics / Pharma Industry, or equivalent experience (or master's degree in a scientific field + 2 years' experience or Ph.D.).

Experience

• Follow Environmental, Health and Safety policies and procedures and ensure a safe and healthy workplace environment. 
• Ability to self-motivate, prioritize work and time. 
• Demonstrates a foundation in general scientific practices, principles, and concepts. 

• Writes and communicates effectively. 
• Ability to work both independently and as part of a team. 
• Knowledge of current Good Manufacturing Practices and US/EU regulations.
• Intermediate knowledge of statistical methods used for Pharmaceutical Process Analysis is a plus. 
• Knowledge of intermediate to advanced statistical analyses and advanced knowledge of mainstream statistical software analysis programs such as JUMP.
• Proficient in Microsoft Word and Excel. 
• Ability to stand for prolonged periods of time and gown into manufacturing areas. 

Relocation Benefits

This position does not offer relocation benefits. 

Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. 

Apply today! http://jobs.thermofisher.com

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. 

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