**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office **Job Description** **How will you make an impact?** The ThermoFisher Scientific St. Louis site is a multi-product and multi-client biopharmaceutical site with manufacturing facilities for pharmaceutical products for both (pre)clinical trials and commercial applications. The Engineer II fulfills several key functions within the team; Management of quality records and compliance tasks, management and tracking of work orders and workflow for the site’s fit and finish program, GMP documentation support for capital projects and SAP/CMMS support for the department. The Engineer II role is part of the Engineering team and reports to the Manager of Manufacturing Engineering. **What will you do?** + Track all quality records for the engineering department to ensure on-time completion for all records. + Support initiation of new quality records as required for engineering / capital projects. + Drive closure of intermediate tasks on quality records to ensure departmental compliance/on-time completion. + Track metrics and workflow of fit and finish program. + Support routine fit and finish inspections of the facility. + Support coordination of external contractors to complete work in the production suites. + Serve as departmental SME on CMMS usage for creating, tracking and closing work orders for work performed within the engineering department. + Serve as a primary point of contact during audits (internal, external, regulatory) and work with the compliance team to provide timely, accurate information to support audit requests related to facilities and engineering. + Support the authoring of GMP documents as the need arises to support engineering department objectives. + Support start up and commissioning activities on capital projects as the need arises. **How will you get here?** + Bachelor’s Degree or higher education in Engineering (Chemical, Mechanical, Electrical, Bio) or equivalent experience in the pharmaceutical industry and related degree. + Associates Degree and 2+ years of related professional experience. + GED and 5+ years of related experience. + 2+ years of industry experience or experience in a similar industry + Past experience managing work orders in SAP or equivalent CMMS software **Knowledge, Skills, Abilities** + Excellent written and verbal communication + Strong attention to detail + Proficient with Microsoft Office tools. + Experience using CMMS software to manage work. + Experience authoring documents in a GMP setting. + Experience working in a cleanroom. + Prior experience working on commissioning and validation in a pharmaceutical setting. At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. 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.