Senior Validation Engineer

The Opportunity:
At Avantor, people are the most important part of our success because they drive our global performance. Thats why our Operations, Lab Services, Sales, and many other Avantor teams rely on our talent acquisition initiatives to attract, engage and hire the right talent. Avantors Quality Control and Validation vertical is a crucial part of this mix, enabling all our internal teams worldwide to grow beyond their limits.
The Sr. Validation Engineer will provide specialized knowledge in developing the strategy for equipment for processes and works with the validation team to ensure proper installation, operational and performance qualification of each piece of equipment up to and including all associated documentation. This includes products for medical device, excipient and bio-pharma manufacturing. Prepares all protocols and reports for validation work. Coordinates all validation activities by constant communication with affected departments and personnel; oversees and reviews validation area processes and procedures. The Sr. Validation Engineer is responsible for the theory and content of validation documents for equipment, processes, systems, software, changes and on-going review and revalidation of said items to ensure that validation documentation is compliant with validation requirements and policies. Provides facility, equipment and process qualification technical expertise. Author validation documents and execute validations of equipment, control systems and production processes. Directs the life cycle of launched products to support development of manufacturing processes, drive right-first time metrics, and reduce product rejects. Has responsibility for self-identification of process optimization opportunities, and detailed assessment of opportunities (process risk, financial cost/benefits, etc.). Participates in cross-functional assessments, as required to evaluate optimization opportunities/issues. Coordinate and lead validations to assure compliance with customers requirements, ISO 9001 & 13485, 21 CFR 210 & 211, 21CFR 820 ICH Q7 and IPEC for all departments within Avantor.
This position will report to the QC Manager and will report to our Solon, OH location.
What were looking for:
Education: BS degree in Engineering or Life Science (Chemistry, Bio, Physics, etc.) preferred
Experience: 4 years of experience in an Equipment, Cleaning, Computer System, and/or Process Validation Engineering experience within a pharmaceutical or medical device company
Knowledge of Industrial Quality Control, Quality Engineering, Quality Assurance and Validation, CFRs and their application to Medical Devices
Knowledge of software packages supporting statistical data analysis, word processing, flow charting, and project management
Familiarity and understanding of manufacturing methods related to the production of medical devices and related products
Familiarity and understanding of technical disciplines related to Quality Control, including Engineering and process controls
Who you are:
Use of computers and peripherals related to validation execution and document authoring
Strong communication skills, both verbal and written; ability to work and interface with all levels of the organization
Ability to work independently and as a team member, as well as, with Consultants/Contractors to achieve projects validation objectives
Ability to analyze, investigate and propose approaches to technical and regulatory issues
Ability to manage multiple concurrent tasks/studies
Ability to execute the Validation Plans for medical device and related product manufacturing equipment and facilities
How you will thrive and create an impact:
Interface effectively with management personnel in IT, Engineering, Quality, R&D, Sales and other technical disciplines.
Provide technical decision making regarding validation strategies and require