Sr. Validation Engineer

The Opportunity:

Avantor is looking for a Sr. Validation Engineer to 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 customer’s requirements, ISO 9001 & 13485, 21 CFR 210 & 211, 21CFR 820 ICH Q7 and IPEC for all departments within Avantor.

This role will be a hybrid position based out of our Solon, Ohio facility (or near other Avantor sites - St. Louis, Kentucky, Phillipsburg, NJ) with 25% travel for projects.

What we’re looking for:

• Education: BS degree in Engineering or Life Science (Chemistry, Bio, Physics, etc.) preferred

• Experience: 5+ years of experience in an Equipment, Cleaning, 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

• Strong communication skills, both verbal and written; ability to work and interface with all levels

• Use of computers and peripherals related to validation execution and document authoring

• 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

• Ability to travel to other sites.

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 requirements for large scale and complex projects.

• Author and approve validation plans, validation protocols, risk assessments, traceability matrices, validation reports, and other documents supporting validation for new and existing manufacturing equipment and processes.

• Perform, coordinate, and manage qualification testing.

• Represent Company in contacts with regulatory agencies, including interface with FDA inspectors and presentations to FDA management personnel in regards to validation activities.

• Coordinate the DQ, IQ, OQ, PQ and PV of all validation activities to assure compliance with customer requirements, ISO 9001 & 13485, 21 CFR 210 &a