Deviation Investigator II

Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Location/Division Specific Information
Work Location: Cambridge, MA

At Viral Vector Services (VVS), a division of Thermo Fisher Scientific, we manufacture the latest viral vector therapies. We offer the expertise and resources necessary to help clients bring their drug discoveries from process development though clinical supply and commercial manufacturing. VVS is located at the forefront of ThermoFisher’s leading and groundbreaking Cell and Gene Therapy business, enabling clients to cure genetic, rare, and otherwise untreatable diseases.

How will you make an impact?

The Deviation Investigator II will be part of a cohesive team responsible for owning/supporting Deviations and CAPAs for all phases of manufacturing.  The Deviation Investigator II uses expert knowledge of cGMP regulations, process knowledge, and investigational skills to support manufacturing compliance. The incumbent will support documentation, training, and improvement initiatives within manufacturing operations. 

What will you do?

• Lead and own manufacturing investigations, utilizing root cause analysis tools as required to find root cause and contributing factors
• Identify event impact and communicate/present to Manufacturing and Quality
• Definition, ownership, and/or support of corrective and preventative actions (CAPA’s) in alignment with Manufacturing requirements
• Utilize manufacturing process knowledge and investigational skills to identify and resolve manufacturing issues and drive continuous improvement in process operations 
• Edit cGMP documents and process through workflow for the creation of quality approved documentation
• Cross-functional collaboration with document control and other supporting groups is required
• Support manufacturing internal and external observations as required
• Practice and promote safe work habits while adhering to safety procedures and guidelines
• Support and develop consistent manufacturing/quality standards and/or process for Deviations and CAPAs in Quality Systems 
• Conduct complex document revisions and/or document management including batch production records and manufacturing procedures 
• Own and maintain tracking systems of manufacturing compliance priorities    
• Work collaboratively with others to meet group and organizational goals
• Participate in initiatives to support innovation and continuous improvement activities 
• Improve compliance within quality procedures, policies, and regulations 
• Participate in client and planning meetings as requested. Including but not limited to presentation and document preparation 

How will you get here?

Education

• Bachelor’s degree in the Life Sciences, Engineering preferred 
• Minimum of 5 years’ experience in pharmaceuticals manufacturing

Experience

• Ability to function in a fast paced, dynamic environment with multiple priorities simultaneously 
• Strong planning, organization, and multitasking skills 
• Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community
• Ability to make decisions and work with minimal to moderate supervision
• Able to provide effective written or verbal communication to peers, senior associates, and area management within their operational groups  
• Solid understanding of applicable regulatory requirements
• Filling Operations Experience is preferred 

Knowledge, Skills and Abilities

• Gown aseptically and/or sterile gown as needed
• Write, read/review written documentation for extended periods of time.
• Specific vision requirements for this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus
• Regularly required to talk and hear
• The employee is frequently required to sit and stand for extended periods
• The employee is occasionally required to lift, stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, or crouch

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.

Salary : $1 - $40